ThesisPDF Available

Development of an Architecture for a Tele-Medicine-Based Longterm Monitoring System

Authors:

Abstract and Figures

Every day gigantic amounts of digital data are produced by billions of devices around the globe. Using this kind of data and develop applications of unlimited possibilities have created the Internet of Things (IoT) idea. Furthermore, wearable devices have taken up the recognition not only for private users, but also medical device producers and start-up companies. They have realized the potential of wearables in medical applications and their importance for the future of tele-medical systems, when being combined with an IoT based architecture. Despite the development of recent tele medicine platforms, none has used printed electronics to obtain physiological signals. This thesis will provide a description of an architecture, that not only uses an IoT application as backbone, but also a hybrid printed electronics design for ECG and Bioimpedance Pneumography measurements. The recorded bio-signals are transferred via Bluetooth Low Energy to a mobile gateway and then onto a server. On the server the data will be processed in order to obtain features of each signal that provide significant information about the patient’s health. Finally this data is stored in a backup system and can be viewed through a graphical user interface. As this thesis is rather a literature review than an experimental work, there will be no methods segment. An extensive background with the state-of-the-art technologies will be provided. The description of the architecture, shows that all the principal layers of an IoT application are met. Issues that arise with the usage of these systems are critically evaluated. This is the basis for researchers in the DISSE (DISappering SEnsors) project, in order to enable them to see the overall picture around their work within the project.
Content may be subject to copyright.
LUKAS HERMANN BENJAMIN TIETZ
DEVELOPMENT OF AN ARCHITECTURE FOR A TELE-
MEDICINE-BASED LONGTERM MONITORING SYSTEM
Master of Science Thesis
Examiner: Prof. Jari Viik and Prof. Jukka Vanhala
Examiner and topic approved by the
Faculty Council of the Faculty of
Natural Sciences
on 6th April 2016
i
ABSTRACT
LUKAS HERMANN BENJAMIN TIETZ: Development of an Architecture for a
Tele-Medicine-Based Longterm Monitoring System
Tampere University of Technology
Master of Science Thesis, 47 pages, 1 Appendix page
May 2016
Master’s Degree Programme in Biomedical Engineering
Major: Medical Physics
Examiner: Prof. Jari Viik and Prof. Jukka Vanhala
Keywords: Telemedicine, Internet of Things, IoT, mHealth, eHealth, wireless Healthcare
system, printed electronics, Wearables
Every day gigantic amounts of digital data are produced by billions of devices around
the globe. Using this kind of data and develop applications of unlimited possibilities
have created the Internet of Things (IoT) idea. Furthermore, wearable devices have
taken up the recognition not only for private users, but also medical device producers
and start-up companies. They have realized the potential of wearables in medical
applications and their importance for the future of tele-medical systems, when being
combined with an IoT based architecture. Despite the development of recent tele-
medicine platforms, none has used printed electronics to obtain physiological signals.
This thesis will provide a description of an architecture, that not only uses an IoT
application as backbone, but also a hybrid printed electronics design for ECG and
Bioimpedance Pneumography measurements. The recorded bio-signals are trans-
fered via Bluetooth Low Energy to a mobile gateway and then onto a server. On
the server the data will be processed in order to obtain features of each signal that
provide significant information about the patient’s health. Finally this data is stored
in a backup system and can be viewed through a graphical user interface.
As this thesis is rather a literature review than an experimental work, there will be
no methods segment. An extensive background with the state-of-the-art technologies
will be provided. The description of the architecture, shows that all the principal
layers of an IoT application are met. Issues that arise with the usage of these systems
are critically evaluated. This is the basis for researchers in the DISSE (DISappering
SEnsors) project, in order to enable them to see the overall picture around their
work within the project.
ii
PREFACE
This thesis was done at the Tampere University of Technology (TUT), in the depart-
ment of Electronics and Communications Engineering in 2016. The design for the
architecture was part of the Disappearing Sensors project, shortly DISSE project,
funded by TEKES.
I would like to thank my supervisor Professor Jari Viik for giving me this opportu-
nity. I am grateful for his patience during the time it took to finalize the thesis and
for his guidance and advice given for the research and thesis. I would also like to
thank the whole DISSE research group for providing an inspiring and communicative
working environment.
In addition, I would like to thank Pekka Iso-Kettola for the inspiring talks and
important hints; Professor Jukka Vanhala and Assistant Professor Matti Mäntysalo
for the more than useful comments for my work. Also I’d like to thank Shadi
Mahdiani for being a very supportive and creative desk neighbor.
Thanks to my family and friends for the support during the process of writing; The
motivational team that kept me going (Annu, Defne and Paul) and the gaming team
that kept being a welcome diversion during my time at the university. Also, a special
thanks to Marlitt Viehrig for understanding, love, support, laughs and motivation.
Tampere, 15.5.2016
Lukas H. B. Tietz
iii
TABLE OF CONTENTS
Preface ....................................... ii
ListofAbbreviations................................viii
1. Introduction................................... 1
2. Background................................... 3
2.1 Tele-Medicine and Monitoring . . . . . . . . . . . . . . . . . . . . . . 3
2.1.1 Bio-Signal Measurements . . . . . . . . . . . . . . . . . . . . . . 5
2.1.2 Wireless Communication . . . . . . . . . . . . . . . . . . . . . . 8
2.2 WearableTechnology........................... 12
2.2.1 The Self Control Movement . . . . . . . . . . . . . . . . . . . . . 12
2.2.2 ’Wearables’ in Medical Applications . . . . . . . . . . . . . . . . 14
2.3 InternetofThings............................. 16
2.3.1 TheIoTIdea............................. 16
2.3.2 Available Platforms . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.4 Biosecurity ................................ 22
2.4.1 Cybersecurity for medical devices . . . . . . . . . . . . . . . . . . 23
2.5 Standardization of Digital Medical Records . . . . . . . . . . . . . . . 25
2.5.1 Standardization ........................... 25
2.5.2 Available Standards . . . . . . . . . . . . . . . . . . . . . . . . . 26
3. Description of the Architecture . . . . . . . . . . . . . . . . . . . . . . . . 29
3.1 ThePatientSite.............................. 30
3.1.1 Printed Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.1.2 MeasurementUnit .......................... 33
3.1.3 Wireless Communication Unit . . . . . . . . . . . . . . . . . . . . 34
3.1.4 MobileGateway ........................... 35
3.2 TheServerSite .............................. 36
iv
3.2.1 Data Processing and Analysis . . . . . . . . . . . . . . . . . . . . 37
3.2.2 DataStorage............................. 38
3.3 TheUserSite ............................... 38
3.3.1 UserProles ............................. 39
3.3.2 Graphical User Interface - GUI . . . . . . . . . . . . . . . . . . . 41
4. Discussion.................................... 43
4.1 Design Flaws and Problems . . . . . . . . . . . . . . . . . . . . . . . 43
4.2 FutureOutlook .............................. 44
4.2.1 Software Enhancing . . . . . . . . . . . . . . . . . . . . . . . . . 44
4.2.2 Hardware Enhancing . . . . . . . . . . . . . . . . . . . . . . . . . 45
5. Conclusion.................................... 47
References...................................... 48
APPENDIX A - The complete Architecture . . . . . . . . . . . . . . . . . . . 54
v
LIST OF FIGURES
2.1 TeleHealthcare .............................. 4
2.2 Impedance Pneumography Electrode Arrangement . . . . . . . . . . . 6
2.3 Screen printing principle . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.4 Bluetoothprinciple............................ 9
2.5 GSMStructure .............................. 11
2.6 IFitbit Product Palette . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.7 ADAMM.................................. 15
2.8 Internet of Things Reference Model . . . . . . . . . . . . . . . . . . . 17
2.9 Internet of Thing Technology Roadmap . . . . . . . . . . . . . . . . . 19
2.10ThingWorxComposer .......................... 20
2.11 Authentification Process . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.12KANTAPrinciple. ............................ 27
3.1 Complete Architechture Functionality . . . . . . . . . . . . . . . . . . 29
3.2 ThePatientSite.............................. 30
3.3 Packaging and Transmission Process . . . . . . . . . . . . . . . . . . 31
3.4 Printed Electronics Layout . . . . . . . . . . . . . . . . . . . . . . . . 32
3.5 MeasurementUnit ............................ 33
3.6 Wireless Communication Unit . . . . . . . . . . . . . . . . . . . . . . 34
3.7 TheServerSite .............................. 36
vi
3.8 TheUserSite ............................... 39
3.9 Graphical User Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . 41
1 Complete Architechture Functionality . . . . . . . . . . . . . . . . . . 54
vii
LIST OF TABLES
2.1 IoTLayerStructure............................ 17
3.1 ExampleDataTable ........................... 36
viii
LIST OF ABBREVIATIONS
2G 2nd Generation mobile Networks
3G 3rd Generation mobile Networks
4G 4th Generation digital cellular Networks
ADAMM Automated Device For Asthma Monitoring And Management
BI Biological Impedance
BIA Bioimpedance Analysis
Bio-signal Biological Signal
BIP Biological Impedance Pneumography
BLE Bluetooth Low Energy
BR Basic Rate
BSS Base Station Subsystem
BT Bluetooth
DISSE Disappearing Sensors project
DVB-T Digital Video Broadcasting - Terrestrial
ECG Electrocardiography
EDR Enhanced Data Rate
EIP Electrical Impedance Pneumography
ETSI European Telecommunications Standards Institute
eHealth electronic Health
FDA United States Food and Drug Administration
GAO Government Accountability Office
GATT Generic Attribute
GPRS General Packet Radio Services
GPS Global Positioning System
GSM Groupe Spécial Mobile, Global System for Mobile Communications
GUI Graphical User Interface
HL7 Health Level 7
IEC International Electrotechnical Committee
IoT Internet of Things
IoT GSI Global Standards Initiative on Internet of Things
IoE Internet of Everything
ITU International Telecommunication Union
LTE Long Term Evolution
ix
mHealth mobile Health
NFC Near Field Communication
PAN Personal Area Network
SIDG Bluetooth Special Interest Group
SMS Short Message Service
TPU Thermoplastic Polyurethane
UMTS Universal Mobile Telecommunications Service
WLAN Wireless Local Area Network
1
1. INTRODUCTION
The development of using smart devices in everyday life has lead to a revolution
of internet capable devices. Smart phones, smart watches, activity trackers and
other wearable devices are connected to each other and the omnipresent internet.
Today, every second more than 28875 Gigabytes of data are created and a large
part of it is uploaded into the internet and by 2018 this number is estimated to be
almost doubled [1]. With the increasing sells of fitness and mobile health (mHealth)
devices the part of this data that represents medical data is increasing daily. The
trend for performing self-control, or personal health is continuing. This also sup-
ports the research in wearable technology that can record and assess medical data,
which exceeds step counts and heart rate determination. Currently, more than
100000 mobile applications that deal with health or medical background are avail-
able for smartphones [1]. Whole wearable electrocardiography and blood pressure
measurement devices are now in development [2]. With this research not only the
private customers profit, but also the medical sector can improve its’ capabilities:
remote monitoring systems are an idea already from the 1960s, but enabled through
permanently online smart devices and wireless technology telemedical homecare or
healthcare systems are closer to publication than ever. The Internet of Things (IoT)
or Internet of Everything (IoE) ideas are right now dictating the developments in
mobile and digital sectors [3].
It is a challenge to develop a modular and expandable tele-medical systems, and,
although, medical device producing companies are offering their in-house and com-
plete solutions, they are ofter very expensive or incompatible with other, existing
systems. This makes a market introduction merely impossible as hospitals or other
healthcare providers often cannot make an investment into a system that is not
compatible with their already existing ones.
Another issue with already presented telemedical architectures is that they often
rely on wired technology and then the collected data is transfered onto a server,
1. Introduction 2
where medical professionals can retrieve the data important for diagnostics. Even
novel designs are still relying on the usage of cables, as [2] shows. To provide a
truly innovative and forward-thinking telemedical architecture, one has to consider
also new technologies: Stretchable printed, ultra-light electronics and an Internet
of Things based approach can enable a true wireless system. Integrating electronic
structures in clothing that then are connected to a internet-capable device is a fairly
new idea and a good start for thinking about integration of new technologies in a
tele-medical application.
The goal of this thesis is to describe such an architecture and to evaluate its impact
onto the future of tele-medical systems. A complete basis for the development of the
individual parts and their combination will be provided. All pieces will be described
individually to enable the researchers of the Disappearing Sensors (DISSE) TEKES-
project, of which this work is a part, to combine their individual systems to one
working proof-of-concept prototype system. This will be tested in the facilities of
Koukkuniemi Home for the Elderly in Tampere, Finland.
The architecture will incorporate a wearable piece of clothing in form of a T-shirt
provided by Clothing+, in which screen-printed, strechable electronics are lami-
nated. Rigid electronic units attached to the stretchable substrate are enabling
Electrocardiography and Electrical Impedance Pneumography, as well as wireless
communication via Blutooth Low-Energy to a mobile reciever. From this gateway
smart phone, which is provided by Elisa Oy, data is transfered via a mobile internet
connection that is based on Global System for Mobile Communications (GSM) to a
Finnish located server, on which the data is processed and stored. Finally, users can
access the data via a graphical interface and through different profiles that allow
different levels of access.
In Chapter 2 of this thesis, the background for this work is covered, by briefly
taking a look at the important bio-signals and their measurements, then wireless
communications that are important for tele-medical applications, lastly the Internet
of Things idea is also examined, together with challenges for biosecurity and the
standardization of medical records. In Chapter 3 the architecture will be described
in its three main parts: the patient site, the server site and the user site. The
Discussion, Chapter 4, will cover the flaws of this design and suggestions for the
possible and necessary enhancements are made. Chapter 5 concludes this work.
3
2. BACKGROUND
2.1 Tele-Medicine and Monitoring
Over the course of more than 40 years tele-medicine has developed rapidly. Being
defined as "the use of medical information exchanged from one site to another via
electronic communications to improve a patient’s clinical health status" 1[4]. The
focus mainly lays on giving patients remotely the assistance to treat their (chronic)
conditions [5]. The usage of telemedical systems should decrease the number of
longterm hospitalized patients and, therefore, the costs for any medical institution
with patient beds. Also, increasing the patients’ comfort who can recover either at
his own home or any other familiar environment and decreasing the need for frequent
visits at the hospital [6]. Furthermore, medical or healthcare information systems
will support clinical decision making in the future [7].
The development of more capable hard- and software enable more complex services
to be included into tele-medicial applications. Faster microprocessors make it possi-
ble to create real-time analysis of the patient status, utilizing compilation methods of
several measurement devices. Smartphones and webcams enable face-to-face-video
doctor-patient-interaction. Smaller medical devices do their part for making physi-
ological measurements portable. Over the years, multiple attempts have been made
to exploit different infrastructures, in order to make remote medical access possible,
e.g. the DVB-T approach from 2008 in [6]. Still, mainly inter- and intranet-based
technologies are the ones that will lead the market [8, 9].
A modern approach to a tele-medical system is shown by Wang in [10]. A com-
plete system is described, which consists of medical devices that are linked wireless
to receivers and those are connected to a server. On the server a medical record
database is located, as well as decision supporting and data processing algorithms
1American Telemedicine Association. ’What is Telemedicine?’, 2012. [Online]. Available:
http://www.americantelemed.org/about-telemedicine/what-is-telemedicine.Vwz46mNQ5SU. [Ac-
cessed 12- Feb- 2016]
2.1. Tele-Medicine and Monitoring 4
are run. Medical Staff as well as the patient shall be able to access recorded data via
an interface. All connections are secured with state-of-the-art encryption. As the
system is proposed to be applied in the whole country of Taiwan, standardization
suggestions for the medical records are also proposed. In figure 2.1 an overview of
the systems schematics is shown.
Figure 2.1 A TeleHealthcare system consists of different parts and grants access to user
groups. Central to most modern Telemedical systems is a server, which stores and manages
digital data [10].
The development of high-speed mobile data connections, like Fourth Generation
digital cellular Networks (4G) and Long Term Evolution (LTE, see chapter 2.1.2),
in latter years now enable even more applications. An ECG measurement recorded
on a smart phone and sent to the hospital in advance, can reduce the decision-making
time for cardiologists and cardiac patients by a significant amount of important time.
The doctor can already make decisions on the status before the patient is even at the
medical institution. Mobile devices will therefore play an; if not the most; important
role in the devolpment of future tele-medical systems, this is the so-called mobile or
electronic health (mHealth or eHealth) movement [11].
In the following sections the basic topics for a tele-medicine system will be explained
in more detail; starting with the biological signals and their measurements that are
important for this thesis: Electrocardiography and Electrical Impedance Pneumog-
raphy. Followed by the wireless connection standards: Bluetooth Low-Energy and
mobile data connections (GSM, 3G and 4G/LTE), which shall be taken advantage
of in the connectivity of the, in chapter 3, described architecture.
2.1. Tele-Medicine and Monitoring 5
2.1.1 Bio-Signal Measurements
Bio-Signals
Biological signals (bio-signals) are phenomena that are used to describe the func-
tional state and the change of state of a living organism or parts thereof. They
provide information on metabolic, morphological and functional changes, describe
physiological and pathophysiological states, and the dynamics of processes. For their
analysis, the origin and, thus, the spatial and temporal allocation is important. They
are obtained from living organisms, organs and -parts or individual cells. Basically
two categories can be distinguished: deterministic and stochastic bio-signals [12, 13].
Electrocardiography - ECG
Electrocardiography (ECG) has not significantly changed over the course of the
last few decades. The basic Einthoven-three-lead, or bipolar acquisition, as well
as the extended 12 lead method techniques are still clinical standard. Utilizing 10
electrodes that are placed on the subjects body, this is the most important non-
invasive (cardiac) diagnosis supporting test. The resulting ECG waveform is the
representation of the heart muscles’ combined electrical activity during different
time points of a heart beat. A healthy person is classified with a constant rhythmic
60-75 R-peaks or beats-per-minute ECG. The R-peak marks the highest amplitude
in an ECG wave of one heart beat [14, 15].
Different durations of ECG can support the diagnosis of chronic or acute diseases.
Short term measurements are usually used for a general assessment, whereas long
term recordings are carried out if a chronic suffering is suspected. What all, of
the nowadays made recordings, have in common is that they are recorded digitally.
The electrical signal is lead via the electrodes and leads towards the electro-cardio-
graph. After analog-digital conversion and filtering, the signal is usually displayed
at a screen and, basically always, stored in the devices own memory for later access.
However, over the course of recent years the digital recording has brought significant
changes into how the data of ECG measurements is stored. In the literature 39
different digital formats have been reported, originating from the manufacturers
or standardization organizations like Healthlevel 7 (HL7), The United States Food
and Drug Association (FDA) or the International Electrotechnical Committee (IEC)
2.1. Tele-Medicine and Monitoring 6
[16].
Electrical Impedance Pneumography - EIP
Biological Impedance (Bio-Impedance), or the resistance of tissue, has multiple ap-
plications. The most common one nowadays is found in body composition measure-
ments, named bio-impedance analysis (BIA), where the percentage body fat com-
pared to muscle and other tissues is determined [17]. Utilizing basically the same
principle of feeding a high frequency, low current electrical voltage via two electrodes
to the body and measuring the impedance between two different electrodes, is also
the electrical impedance pneumography (EIP) [18].
EIP is used to determine the breathing frequency. The impedance changes with the
breathing process. While breathing in the impedance is increasing and vice versa.
the alternating impedance is measured with two or four electrodes placed on the
side of the chest (see figure 2.2). The recorded signal is of deterministic character,
which makes it easy to determine certain features out of it [19].
Figure 2.2 Impedance Pneumography is carried out in two configurations: A) with two
electrodes and B) with four electrodes [20].
Current Technologies have not much changed since the 1990s. The technique how-
ever is still widely and commonly used [20].
2.1. Tele-Medicine and Monitoring 7
Printable Strechable Electronics
Measurements relying on conductive methods are usually done with electrodes at-
tached to the body’s surface. Self-adhesive electrodes ensure skin contact and a
small transition resistance, which is needed for accurate measurements [13]. How-
ever, skin attached electrodes have the disadvantage in various situations during
daily life. Therefore, another method has to be applied when conducting long term
measurements. Not only the electrodes do have an impact on daily life, but also the
leads, that transport the electrical current from the electrode towards the measuring
element. They have to be affixed to the body with plasters or similar, in order to
not hinder the patient.
ECG and Bio-Impedance measurements, both rely on conductive contact to the pa-
tients’ skin. To avoid having to use cables for conduction, printable and stretchable
leads and electrodes have been introduced. These components can be produced
together in one step. There are different methods of printing these structures, as
well divers materials can be used [21]. It has to be mentioned that not only the
ink is the stretchable part in the applications, but also the underlying substrate. In
most cases this is a flexible Thermoplastic Polyurethane (TPU) sheet, on which the
conductive ink is printed on.
Utilizing screen printing, a technique where the desired image is masked on a mesh,
with impermeable areas around it, and the ink is transfered through said mesh onto
a substrate [22]. Especially for stretchable electronics this very old technique is
favored, since the deposition of ink can be done with high control [23]. The process
is depicted in figure 2.3, showing the three steps of ink depositing through a mesh
grid onto a substrate [24].
Using a conductive ink instead of regular ink, one can print structures onto the
substrate that are acting as a electrical circuit. Those flexible circuit boards can
include structures, where solid electronic components can be mounted using certain
techniques, for example gluing them on, using conductive glue. Those combinated
structures are called hybrid systems [23].
2.1. Tele-Medicine and Monitoring 8
Figure 2.3 The principle of the screen-printing process [24].
2.1.2 Wireless Communication
Bluetooth/Bluetooth Low Energy - BT/BLE
Bluetooth (BT) technology is a global wireless standard for short-range, packet
based communication. It was introduce in 1994 and intended as replacement for
cable connections. BT utilizes radio transmission to send data between devices
equipped with an appropriate module. Designed to be an open standard, Bluetooth
enables connectivity and collaboration between different devices, brands, even in-
dustries. The worldwide spread of this technology, basically makes it the enabler
of IoT technology. Lately, medical devices also have been equipped with BT radios
to be able to communicate wireless. Nowadays, the most common application for
BT are wireless headphones or speakers, such as in hands free car accessories [25].
Generally, there are three different types of Bluetooth connections:
1. Bluetooth Basic Rate (BR)
2. Bluetooth Enhanced Data Rate (EDR)
3. Bluetooth with Low Energy Functionality (BLE)
2.1. Tele-Medicine and Monitoring 9
While the first two types are commonly used in larger electronic devices, e.g. wireless
headsets or printers; Bluetooth Low-Energy, or so called Bluetooth Smart R
, is
utilized in micro sensor systems or smart devices. Later in this section BLE will be
discussed in more detail. All these types, however, operate in the same unlicensed
industrial, scientific and medical (ISM) band at 2.4 to 2.485 GHz, to ensure no
interferences with other wireless communications like Wireless Local Area Network
(WLAN) or Global System for Mobile Communications (GSM) [26].
Figure 2.4 The principle of Bluetooth connections [27].
Bluetooth enabled devices connect between a Master device and a Slave device.
Thereby, a master can have up to 7 slave devices connected to it in a Personal Area
Network (PAN), the so called piconet environment. In figure 2.4 The connection
principle is shown. It is also depicted that a slave device can be a connected (paired)
to multiple master devices [27].
Each device has its own, unique 48 bit address. In order to connect two devices the
following steps are either done automatically or manually, if the connection is made
for the first time [27]:
1. Device A is activated and searches for available connections
2. Device B is found, the pairing process is started
2.1. Tele-Medicine and Monitoring 10
3. Pairing process: the identities of both devices are exchanged
4. The pairing is finished
5. A Personal Area Network (PAN) is formed
6. The connection is operable
Bluetooth Low-Energy Modern Bluetooth devices that are classified as Blue-
tooth Low-Energy or Bluetooth Smart R
are more power efficient than earlier ver-
sions. This standard is applied to many devices since 2010, and was originally intro-
duced as Wibree by Nokia in 2006. The technology now enables developers to create
systems that include sensors, microprocessors and a Bluetooth Low-Energy module,
which are powered by not more than a single coin battery. Power harnessing tech-
niques might even provide a longer lifetime to those systems, if not unlimited life.
This already is applied in wearable technologies, where small batteries power the
devices multiple days or weeks with a single charge, despite a permanent bluetooth
connection with a mobile phone [25].
While BR and EDR rely on determined profiles and protocolls, BLE was developed
on the basis of a development framework that utilizes Generic Attribute (GATT)
[25]. These attributes are used by the developers to build so called profiles. The
GATT can be assigned and determine which information is sent during a connection
process, or which services can be used by the connection partners. With this, basi-
cally any device can be equipped with a bluetooth module and, the correctly built
profile presumed, will be able to communicate with any other device that supports
the standard. A number of basic profiles and services that utilize GATT is available
on the web page of the Bluetooth Special Interest Group (SIG) [28].
GSM/3G/4G mobile Networks
This section will give a closer insight into mobile cellular networks. The commu-
nication via Global System for Mobile Communications (GSM), third generation
cellular networks (3G) and fourth generation digital cellular networks (4G) works
via local radio antennas. Each antenna forms a cell around itself, hence the name
cellular networks. According to different standards a mobile telephone is communi-
cating with those local receivers on certain frequencies, which are required by each
2.1. Tele-Medicine and Monitoring 11
standard. These antennas are called Base Station Subsystems (BSS) and are run
by the base station controller which itself redirects the requests from the Mobile
Equipment either for telephone services or for internet services towards the appro-
priate direction. Figure 2.5 depicts the basic structure of a GSM network. All newer
mobile cellular networks share the same basic principle [29].
Figure 2.5 The structure of a GSM network consists, simplified, out of the Mobile Equip-
ment, the Base Station System and the appropriate Core networks for internet or telephone
functionality [29].
Global System for Mobile Communications (originally Groupe Spécial Mo-
bile, GSM), is an international standard developed in 1989 by the European Telecom-
munications Standards Institute (ETSI) for the description of protocols for second-
generation (2G) digital cellular networks. As Finland was leader in mobile phone
coverage, this technology was first deployed in 1991 there [30]. Except in Japan and
both Koreas GSM is the worldwide standard and operates on either 850, 900, 1800
or 1900 MHz in more than 219 countries and territories [31].
GSM also introduced the packet data transport via General Packet Radio Services
(GPRS) in 1995, which was the first mobile data connection. GPRS enables e.g.
Short Messages Service (SMS). The data connection is limited to a download speed
of 64.2 kBit/s and an upload speed of 42.8 kBit/s [30].
A further development of this standard under ETSI is the third generation of mo-
bile telecommunications technology (3G). The third generation was introduced in
2.2. Wearable Technology 12
1998 and required providers to offer a download speed of maximum 200 kBit/s.[30]
The Universal Mobile Telecommunications Service (UMTS) system enabled mobile
internet connections and, other than 2G, is transmitted on the 2100 MHz frequency
[31].
The Fourth Generation digital cellular Networks (4G), or often referred
to as Long Term Evolution (LTE) is the current generation of cellular networks.
Unlike it predecessors, 4G is defined by the International Telecommunication Union
(ITU) and was introduced in 2008. High speed mobile connections are possible with
speeds of up to 1000 MBit/s (only in true LTE), and enable data intensive services
like video streaming and fast internet access [32].
These digital cellular networks, build a base for the communication between a smart
phone and the internet, which makes them the backbone of the Internet of Things
technology. Later this technology is described in more detail and it is shown how
the devices are working together.
2.2 Wearable Technology
Wearable devices are ny sensor bearing device that can be worn by the user, which
is connected to a smart device of some sort. The most common ones are battery
powered activity trackers or sport watches. The biggest challenge in the design of
such a device is the size and its’ unobtrusiveness for the wearer. They have to be
small, light and comfortable to wear. A wireless connection is also necessary, in
order to keep the practicability high. The materials have to be bio-compatible and
bioinert at the same time. The incorporated electronics also have to be minimized
in order to achieve the mentioned properties [33].
2.2.1 The Self Control Movement
As indication to the wearables’ increasing significance might the example of the
self-control movement the most important. In latest years personal tracked fitness
became more important and with the available microfabrication methods sensors
became smaller and, therefore, could be implemented into devices that are small
2.2. Wearable Technology 13
enough to be worn without a large distraction; ’Wearables’ were born. This move-
ment is also called personal health or mobile health (mHealth), as most of the avail-
able devices are to be connected with a smart phone of some sort. The wearable
devices produce a vast amount of information every day, this data can, correctly
treated, support the diagnostic power for patients of any kind. Users of activity
trackers state that the living with these wearables has a positive effect on health
choices and also a positive effect on the amount of movement during the daily routine
[1].
The most important ’wearables’ to be mentioned are the armbands, that give the user
control over different functions as well as the possibility to track the daily movement
profiles or, in special hardware, the heart rate at any given moment. Other function-
alities, like sleep quality measurement and position tracking via Global Positioning
System (GPS) are available depending on price of the device and the respective
manufacturer. So called smart watches not only have the tracking functionalities,
but also offer the control of the smart phone itself and other third party application
interactions directly on the wrist worn device [34]. Normally, the devices connect to
the smart phone and require the corresponding application, to be able to transfer
the recorded data.
The biggest companies in wearable technologies are Apple, Fitbit and Google with
their respective devices: Apple Watch, Fitbit Charge and Android Wear. And the
market for these wearable devices is still growing, given the 168 % growth of the
Fitbit Inc. in 2015 [34]. The Finnish company Polar Electro also offers a wide range
of different devices, from simple step counters to a high-end gadget the Polar V800,
that offers continuous hear rate monitoring and GPS functionality, next to being
waterproof and smart phone control for about 400 e[35].
The self control movement is driven by the willingness to increase one’s personal
health by increasing the daily activity and adjust it towards a more healthy lifestyle.
Thereby, also calorie intake and weight can be tracked. With the option between
the different trackers one can additionally, automatically measure more signals. The
product palette of Fitbit Inc. shows the different types of trackers available from
most companies in the market (see figure 2.6). Starting with a simple step counter,
the Zip, over the Charge, that also offers sleep analysis, to the higher-middle class
devices called Charge HR and Blaze, which offer continuous heart rate monitoring.
The best available device from Fitbit is the Surge, which also allows smart phone
2.2. Wearable Technology 14
control and GPS based location tracking [36]. Next to the wearable tracking de-
vices, many companies started to offer smart scales that also connect via Bluetooth
Smart R
to one’s smartphone.
Figure 2.6 The Fitbit Product Palette starts from simple stepcounters and offers also
high-end devices with heart rate monitoring and GPS tracking [36].
The mentioned smart scales often also offer body composition measurement, that
are done by the earlier described bioimpedance analysis. The choice for using self
control, that is supported by smart devices often starts with the choice to start
a healthier life style, which means: more movement, loosing weight and eating
healthier. Lots of supporting smart phone applications not only connect with a
fitness tracker but also provide the feature of tracking energy (calorie) intake and
food lists, and then give actively meal suggestions [36].
2.2.2 ’Wearables’ in Medical Applications
The trend to use small devices that are connected to a smart phone is not limited to
the private sector. Medical companies also start offering devices that work indepen-
dently with their own applications; The General Electric (GE) Healthcare division
also released an article quoting a video by The New Economy, that wearables will
change the landscape of healthcare and that GE is also addressing the two gen-
eral key of implementing networking between devices and miniaturization of sensing
devices [37].
But not only the ’global player’ GE is developing in that direction, also smaller com-
panies start selling devices with a defined healthcare background. This, potentially,
can result in a more personalized treatment for any patient that uses such devices
and shares the outcomes of measurements with medical professionals. Wearables
can help controlling the movement during exercise to provide feedback, whether the
execution was correct or not. But also other applications can be realized as the
following examples of wearable devices, which support of medical treatments and
diagnosis, show [38].
2.2. Wearable Technology 15
The Valedo Back Therapy is a wearable position observing sensor, that is aimed to
help patients with lower back aches. Reminders for desk workers to stretch their
back once in a while as well as games and suggestions for lower back exercising are
included in the companion application for smart phones [38].
The Quell Relief is an electrical stimulator that is targeted to chronic pain patients.
It is a knee brace for support of movement. Implemented is an electrode that
stimulated the underlying nerves for pain relief on the press of a button. Again,
accessible through a companion app is the interface that provides statistics about
the usage of the device and the quality of sleep [38].
The Automated Device For Asthma Monitoring And Management (ADAMM) by
Health Care Originals provides real time respiratory monitoring for asthma patients.
The product is currently under development and is expected to alert the users when
an asthmatic situation happens. As well journaling, tracking of situations and treat-
ment plans can be displayed in the application. The device is worn on the chest (see
figure 2.7) and connects to the smart phone via Bluetooth [38, 39].
Figure 2.7 The Automated Device For Asthma Monitoring And Management (ADAMM)
by Health Care Originals provides real time monitoring for asthma patients [39].
Targeted on patients that have to use medications regularly is the Helius a swallowed
pill by Proteus Digital Health. The ingestible sensor is taken along side the other
2.3. Internet of Things 16
medications and is sending a signal at the time of ingestion to the worn patch
called Discover, which provides the basic information about the patients health in
form of heart rate measurements, step counting and blood pressure. The resulting
data shows the medical professional whether the patient is taking the prescribed
medicines correctly and what effect those have on the body [38].
A recently intensively studied subject is the early diagnosis of cancer. Breast cancer
is the second most lethal type of cancer for women, therefore, regular check ups are
suggested by medical professionals. A supporting wearable device is the iTBra by
Cyrcadia Health, that tracks conditions and rhythms in the breast tissue and alerts
the user of a possible case of breast cancer. The accompanying application gives
insights on recorded data and provides information about optimal breast health.[38]
2.3 Internet of Things
2.3.1 The IoT Idea
With more advanced technologies, such as high speed mobile connections and low
power short range connections, as the ones described above, new ways to connect
devices to each other were found. The most prominent one right now is Internet
of Things, where the data that is produced by the vast amount of devices, is used
for actuator control, process analysis and other applications. The standardization
of IoT is run by the Global Standards Initiative on Internet of Things (IoT-GSI).
The Internet of Things (IoT) is the network of physical objects/devices, vehicles,
buildings and other items embedded with electronics, software, sensors, and network
connectivity that enables these objects to collect and exchange data. The Internet of
Things allows objects to be sensed and controlled remotely across existing network
infrastructure, creating opportunities for more direct integration of the physical
world into computer-based systems, and resulting in improved efficiency, accuracy
and economic benefit. Experts estimate that the IoT will consist of almost 50 billion
objects by 2020. Cisco showed a reference IoT architecture model, showing all layers
of a IoT application. The schematics in figure 2.8 show the seven general layers of
a structure [40].
These seven general layers are, described from the bottom to top, are shown in Table
2.1 [40].
2.3. Internet of Things 17
Figure 2.8 The visual representation of Internet of Things Model shows 7 layers, from
1) the physical layer to 7) human interactive collaborations and processes [40].
Table 2.1 The IoT Layer Structure according to Cisco Systems, Inc. [40].
Layer Cisco Systems Description
Layer 1 Physical Devices & Controllers
Layer 2 Connectivity
Layer 3 Edge Computing
Layer 4 Data Accumulation
Layer 5 Data Abstraction
Layer 6 Application
Layer 7 Collaboration & Processes
Starting at the physical layer, means the physical sensors and actors in an IoT appli-
cation. Taking a simple example in consideration, remotely controlled agricultural
watering, the physical layer is represented by sensors for temperature and air hu-
midity. As this layer also describes the applications’ actors one has to mention the
valves for the watering lines to the fields, that can open and close, according to need.
The second layer of an IoT application is represented by the connectivity, i.e. how the
sensors provide their collected data to the operation. In the case of the automated
watering system, this is usually done via a GPRS module attached to the sensors,
which directly transfers the data into the internet. In other applications close range
2.3. Internet of Things 18
communication towards an internet capable device are possible, e.g. a Bluetooth
connection to a mobile phone.
The mentioned GPRS module in the example application also introduces the third
layer: Edge Computing. The collected data is transformed into data packages of
chosen sizes and sent into the internet, that usually is presented through a server of
some sort.
Layer four: The data accumulation is the mentioned server, the incoming data from
the GPRS module is unpacked and stored in the intended format for further use.
The temperature and humidity, as well as the status of the valves are stored in an
database table. Also, the average values of temperature and humidity are calculated
and stored.
In the data abstraction step, the collected and stored data is processed for the
intended use in the application. In case of the watering system, the application runs
database queries to receive the values for temperature, humidity and valve statuses.
The application layer of an IoT architecture is usually represented by a user interface,
that allows interaction. The requested values for temperature, humidity and valve
statuses are presented in a graphical user interface (GUI) and the user can interact.
For example see the trend report of the average temperature over the past 7 days,
or control (i.e. open and close) valves with a mouse click or finger tap.
The last layer, which is collaboration and processes, involves usually interaction
between humans utilizing the same architecture. As the watering system is intended
for one farm to use there is no representation of the example for this layer. However,
thinking of a telemedical application of an IoT system, video calls between doctor
and patient can be mentioned. As well, the triggering of an alarm, due to certain
circumstances, is to be named as collaboration.
Viewing the roadmap (figure 2.9) for the IoT technology from 2008, one can rec-
ognize that most of the goals that were anticipated till 2020 are already realized
and find their application in available commercial systems. Of course, the market
for IoT is still very small compared to standard applications, but with the further
reduction in development costs and increasing reliability the market share is sure to
grow. Intelligent or autonomous systems, that measure and control themselves are
as well in development as decision supporting architectures, where a collective in-
2.3. Internet of Things 19
Figure 2.9 The Roadmap for the development of the IoT technology [41].
formation storage will be utilized to draw conclusions and support human decisions.
These artificial intelligence systems are also relying on the Internet of Things idea,
but will not be part of this thesis [41].
2.3.2 Available Platforms
Since the beginning of utilizing the IoT idea numerous different platform arose from
different developing companies. Amongst them are big industry names like Mi-
crosoft, Google and Amazon. But also more specialized platforms have been cre-
ated. One thing that all those platforms have in common is that they aim to make
it easy for users to build applications that are designed for their use, with a set of
tools provided. Generally, available platforms enable the user to build a piece of
software that is able to receive data from a remote device, store it on a server and
use it to display information about it on a graphical interface, which also has been
designed with the platform.
Most of the available platforms focus on industrial applications. Unfortunately,
there was no platform to be found that concentrates solemnly on tele-medical appli-
cations. The common platforms, like Intel, ThingWorx or Kaa, however, only offer
the possibility to build tele-medicine architectures [42, 43, 44].
2.3. Internet of Things 20
ThingWorx
One of the biggest providers, apart from the industry giants, is PTC Inc. with
it’s IoT platform ThingWorx. This is a java based, apache server sited running
application, which allows the user to create his own objects, classes and, lastly,
MashUps. MashUps are the graphical interfaces, that can be created from the given
ThingWorx toolbox. The user creates the interface by drag-and-drop of the elements
that are available and then connects the object, class or event that triggers a change
in the interface. Currently ThingWory is available in version 6.6. A marketplace is
offering a very large add-ons for the platform, to for instance integrate the MQTT
(Message Queuing Telemetry Transport) connectivity protocol enabling machine to
machine messaging. To run a ThingWorx application a server must be provided,
that runs Apache and the Jave Runtime Engine [43].
The backbone of the platform is the composer, which is the interface for developers.
It allows the creation of the different entities, alarms, users, usergroups. In figure
2.10 the composer is shown in a properties tab for defining values [43].
Figure 2.10 The Composer is the developer platform for ThingWorx [43].
It is possible to not only define the objects in this platform, but also certain triggers,
for alarms, which is an important aspect when considering a tele-medical application.
A large disadvantage at the moment of the creation of this thesis is that there is no
mobile application builder introduced yet. However, it’s said to be released in the
summer of 2016. This would enable building applications not only for large screen
devices but also for mobile phones [43].
2.3. Internet of Things 21
Opposite to the other two introduced platforms, ThingWorx is not free for develop-
ment. Instead, different packages can be bought, where the price is depending on
the amount of service that is included in the package.
Amazon Web Services IoT
One of the biggest providers of online services also offers a platform to develop
Internet of Things applications. Amazon Web Services (AWS) IoT offers again the
functionality to bind internet-capable devices into an architecture and control their
stream of data from or towards that device [45].
Again, user profiles and user groups can be defined that can access different parts
of the built applications. In the review of this thesis it was not checked, how com-
plicated the application builder actually is.
Other than the other two platform AWS offers also a wide range of other online prod-
ucts that enhance the capabilities of the IoT platform [45]. However, it seems not
to be as flexible as the other two, concerning the integration of different messaging
protocols.
The AWS IoT offers a unique feature: device shadows. The last known status
of a device is always saved to the database. Those shadows can be used for the
application development as stand ins for a device. Also, they can be used as a
control value, to set the device to a certain state the next time it connects to the
internet [45].
The IoT platform is free for trial and can be used up to one year, still server costs
are not avoidable.
Kaa
Kaa is a relatively young, but open source development platform. It is provided from
CyberVision and again poses as multi purpose platform for end-to-end solutions.
Opposite to the other two introduced platforms, Kaa, is not intended for large scale
applications, despite claiming to handle those as well. It also is Java based, but can
handle C and C++ Software Development Kits (SDK)[44].
2.4. Biosecurity 22
Kaa is available as standalone download for local servers, or can be deployed directly
on AWS servers for free. An advantage of Kaa is the possibility to connect any
already available, wearable device to the intended application and use its data for
analysis.
2.4 Biosecurity
Nowadays, a lot medical devices are connected to a network, creating an interface
between the hospitals, patients and medical device manufacturers. This digitized
network makes medical devices vulnerable to third party interventions, leading to
breach of doctor-patient confidentiality by unauthorized access or hacking. These
risks raise the question of information and network security of all medical devices
including patient monitors, insulin pumps, ventilators, infusion pumps, imaging
modalities and pacemakers [46].
Since 1960s, the Food and Drug Administration (FDA) has considered some unin-
tentional cybersecurity risks, which include the possible interference of radio signals
or electromagnetic fields with implanted medical devices. Consequently, currently
FDA and manufacturers warn the customers on these matters. However, as it was
noted by Government Accountability Office (GAO), intentional threats to certain
medical devices, specifically active implantable medical devices with close range
communication such as Near Field Communication (NFC) or Bluetooth.
In a report, published in 2012, GAO urges the FDA to consider the information secu-
rity for certain types of medical devices such as defibrillators and insulin pumps.[47]
Since then, the FDA has become aware of the importance of cybersecurity risks and
incidents. In June 2013, the FDA published an alert addressing to hospital net-
works and medical device manufacturers to point out the important aspects, risks,
risk management and possible solutions [48].
The current program of the FDA is assessing the security of medical devices. It
requires manufacturers to "assure their customers (for example patients, insured in-
dividuals, providers, and health plans) that the integrity, confidentiality, and avail-
ability of electronic protected health information they collect, maintain, use, or
transmit is protected" 2[49]. Despite of this program, there is no specific guidance
2Department of Health and Human Services, "Health Insurance Reform: Security Standards;
Final Rule," Tech. Rep. 34, 2003. [Online]. Available: http://federalregister.gov/a/03-3877
2.4. Biosecurity 23
or requirement imposed by FDA, thus leading to medical devices varying widely in
their safety features [50].
2.4.1 Cybersecurity for medical devices
Information or cybersecurity consists of data protection, services, systems and com-
munications and controlling the risks against them by administrative, technical or
other measures [51]. Cybersecurity in general consists of three security objectives:
Availability - System must always respond according to its specification and
design
Confidentiality - Data can only be known by intended parties
Integrity - Data cannot be altered without being detected and all systems
affecting patient treatment must not be altered without patient’s knowledge.
Authentication - Only authorized parties should be able to act as a trusted
user of the system
Authorization - Actions of certain authorized parties have to be verified
before implemented.
For Industrial Control Systems, to which also many medical devices belong, this
is also the priority order of these security objectives. Availability means that the
information is available to all authorized entities when they need it. Integrity of data
on the other hand stands for unchanged information, which is accurate and has
not been tampered. Confidentiality requires that the information is not revealed
to unauthorized entities. Sometimes also authentication, meaning that the user
has been recognized corresponding some identity in the system, is attached to the
definition of cybersecurity [51].
In order to authenticate a user of an information system a login procedure is used.
This identifies the user, which has been provided with a unique user name and
password for that specific system. In figure 2.11 a standard login flow graphic is
displayed. This flow is basic to any web service or information system, which utilizes
different users. This is needed in order to either secure data from intruders, or to
separate the data users have access to [52].
2.4. Biosecurity 24
Figure 2.11 The basic authentification process requires user interactions and displays
different screens. After [52].
Data integrity is also important in medical device context. If, for instance, monitor-
ing device gives wrong information to the doctors, it can lead to improper treatment
and cause large risk for the patient. Data from the device should be reasonable, ac-
curate and fit for its purpose. Thus, data integrity is important for safety and utility
reasons. In addition to be able to produce accurate and relevant data, medical de-
vices should be tamper proof in order to preserve the data integrity [53].
Confidentiality and privacy are another important concern in medical device context,
because many devices can contain sensitive information. It is possible, that a patient
does not want any other person to know he or she carries an implantable medical
device. Thus, unauthorized persons should not be able to determine whether a
person carries a medical device nor what ID it has. Therefore, the device-type,
device ID, measurements and any other information regarding to patient should not
be readable from the device by unauthorized persons [53].
On the other hand, only authorized persons should be able to modify device settings
and, the user should not be able to accidentally increase the medicine doses. This
means that devices must be able to authenticate users and possibly use different
2.5. Standardization of Digital Medical Records 25
roles for different users. In terms of medical devices this often means the general
access to the device handling has to be restricted [53].
The ’International Electrotechnical Commission (IEC) 62304 Medical device soft-
ware software life cycle processes standard’ provides a framework for safe design of
medical device software. In practice, companies producing medical device software
must design their quality systems to implement this standard, otherwise it would
be difficult for the software manufacturer to fulfill the regulations for medical de-
vice software. The IEC 62304 mainly describes the steps and guidelines to produce
software that fulfill the regulations called for in the document [54].
2.5 Standardization of Digital Medical Records
Standardization in medical records is mainly used to support patient care. The
general drive to digitize medical records is aimed to improve this support even more.
A general problem with the process is that a standard has to be found which can be
applied to older, paper records, in order to make them comparable and compatible.
Standardization means to structure the records in order to bring direct benefits to
the patient and the care giver [55]. There are different types od standards in medical
records: data standards and terminology standards [54].
2.5.1 Standardization
Data standards provide consistent meaning to data shared among different infor-
mation systems, programs, and agencies throughout a product’s life cycle. These
include representation, format, definition, structuring, tagging, transmission, ma-
nipulation, use, and management of data [54]. Terminology standards control terms
and definitions used in submissions to the FDA. They are often used in combination
with a data standard to aid in exchange and interpretation of data. The purpose of
these standards is to:
Maximise patient safety and quality of care
Support professional best practice
Assist compliance with Information Governance and NHS Litigation Authority
(CNST) Standards
2.5. Standardization of Digital Medical Records 26
Unfortunately, there is no general map of which standards are needed in healthcare.
Currently, standard development is driven by implementation needs and by specific
interest of groups (companies, organizations) or individuals. There is only few gov-
ernment based standardization approaches in the world. Again, those standards are
limited to the countries’ borders and are not internationally compatible. It is clear
that the issues identified in the development of standards have an impact on the
adoption, conformance and compliance in such a diverse range of standards. The
fragmentation of the developments rises difficulties in harmonization and terminol-
ogy which inevitably has an impact on compliance. Furthermore, there are more
issues relating to conformance and compliance which cross over from health software
to mobile applications and medical devices.
2.5.2 Available Standards
Right now there are several standardization approaches in the world, that aim to
unite companies and governments into one level. In Europe, especially the Finnish
Kanta system and the German G1 act for standardization of medical record keeping
are to be named. Both systems have the goal that the medical records are saved
centrally, in a secure, country located server. In order to be able to write data from
any office within these countries, a standard method of patient identification and
terminology has been found. Other than those government based standardization
approaches, there are also organizations, which try to establish a standard that can
be applied in medical applications. The most prominent one is Health Level Seven
(HL7), as an internationally operating organization.
Germany - G1
After years of serveral insurance companies in Germany, the act finally enforced that
each individual is assigned one general ID number, that will not change, even if the
insurance company is changed. This way it is ensured that recorded medical data
and associated records, like prescriptions, can be transfered securely and compatible
to the new insurance. Furthermore, recorded data will be available to medical
professionals from the centralized server. This needs, however, more effort and
time, since the saving of sensitive data on one single location is (still) prohibited by
German law.
2.5. Standardization of Digital Medical Records 27
Finland - Kanta
The Finnish Kanta medical database is aiming for a similar approach: centralizing
the records, in order to keep personnel easy up to date on the patients history. With
the deployment of ePrescription in 2015 a step towards the future has been made.
Figure 2.12 shows that an interoperability of subsystems will be enabled.
Figure 2.12 Kanta is the Finnish medical database [56].
International - Health Level Seven
Health Level Seven (HL7) is an international operating organization with the aim
to provide standard regulations for medical record keeping. The general goal is to
ensure interoperability between systems and care providing organizations. As other
standardization committees HL7 strives to provide a data and terminology stan-
dardization. Lately, HL7 is also focusing on the implementation of mobile health
(mHealth) records and Fast Health Interoperability Resources (FHIR). The latter
introduced a simplified platform for medical device and software producers to im-
plement the HL7 standards in newly developed products [57].
2.5. Standardization of Digital Medical Records 28
Over the course of 30 years, several versions of electronic medical record keeping
standards were published. Generally, HL7 standards are now divided into reference
categories [58]:
Primary Standards - Most popular standards integral for system integra-
tions, interoperability and compliance.
Foundational Standards - Fundamental tools and building blocks used to
build the standards
Clinical and Administrative Domains - Messaging and document stan-
dards for clinical specialties
EHR Profiles - Functional models and profiles
Implementation Guides - Support documents and material
Rules and References - Technical specifications, programming structures
and guidelines for software and standards development.
Education & Awareness - Resources and tools for understanding and adop-
tion of HL7 standards.
29
3. DESCRIPTION OF THE ARCHITECTURE
The aim of this thesis is to describe a base for an architecture, which can be used to
build an proof-of-concept prototype system. This system should generally include
all the major described components in order to measure and evaluate the ECG and
EIP signal of a patient using a wearable shirt that incorporates a hybrid flexible,
printed electronic layout. The Architecture shall be divided into three different
sections, also shown in figure 3.1.
The Patient Site (blue)
The Server Site (green)
The User Site (red)
User Site
Server Site
Patient Site
Printed Electronics Measurement unit
Layer 1
Wireless Communication
Unit
Layer 2
Mobile Gateway
Layer 3
Data
Storage
Layer 4
Data
Processing
Layer 5
Graphical User Interface
Layer 6
User Profiles
Layer 7
Bio-Signals
ECG
BI
Medical
Sta
Patient
Medical
Professional
Figure 3.1 The complete Architecture, which contains all 7 Layers of a IoT system.
Check Appendix A at page 54 for a larger image. With images from [20, 59].
3.1. The Patient Site 30
As visible in figure 3.1 the differentiation is based on the layers of an Internet
of Things architecture (see chapter 2.3.1, p. 16). The physical, connectivity and
Edge computing layers are represented by the Patient site of the architecture. The
printed electronics together with the measurement unit build the physical layer. The
connectivity (Layer 2) is ensured via the wireless communication unit, which utilizes
the BLE112 Smart Bluetooth module by Bluegiga. Lastly, the edge computing is
carried out by the connected smart phone, which is described in the mobile gateway
section.
Furthermore, the Server site (see chapter 3.2) represents the next two layers of an
architecture for IoT based applications. The recorded data is collected on a Finnish
located server (Layer 4: Data Accumulation) and is then processed and saved in a
database format suitable for the utilized IoT platform Thingworx (Layer 5: Data
Abstraction).
The last two layers of the IoT based architecture are found in the User site. As there
will be suggestions for a graphical user interface, the sixth layer is covered. The
seventh level is represented in the user profiles section, where one can understand
that different profiles are needed in order to access the data in different ways.
3.1 The Patient Site
Patient Site
Printed Electronics Measurement unit
Layer 1
Wireless Communication
Unit
Layer 2
Mobile Gateway
Layer 3
Bio-Signals
ECG
BI
Figure 3.2 The structure of the patient site includes various active electronic compo-
nents and a bluetooth connection. For a larger image, in relation to the other sites, check
Appendix A at page 54. With images from [20, 59].
This part of the described architecture deals with the physical devices that are
connected to the patient, or used to record the bio-signals. Therefore, this section
3.1. The Patient Site 31
will deal with the printed electronics and their layout, the measurement unit, which
incorporates the Texas Instruments ADS 1292R and includes a power source, the
wireless communication unit; represented by the Bluegiga BLE112 module; and
lastly the mobile gateway, which communicates and sends the acquired data to a
server located in Finland. Figure 3.2 depicts a short overview of the patient sites’
components and the signal travel.
The transportation of the data between the devices is planned to happen as in shown
in figure 3.3. Tha data recorded by the measurement unit is packed into packages
of a few kilobytes size and sent to the mobile gateway. The mobile gateway unpacks
these and repacks bigger packages in order to send them to the server via GPRS.
Bio-Signals Measurement unit Wireless Communication
Unit
Mobile Gateway Server
ECG
BI
Figure 3.3 The data is recorded and stored in a data format Between the Bluetooth
connected devices small packages are sent, whereas the mobile gateway will unpack the
packages and repack larger ones in order to send them to the server. With images from
[20, 59].
This method is used in order to reduce the connection time between the mobile
gateway and the local Base Station Transceiver. This saves power on the gateway,
because no permanent sending is happening.
3.1.1 Printed Electronics
The electronics that connect the electrodes, which themselves are also part of the
printed, flexible layout, with the two other units that are incorporated into the t-
shirt. The electronics that are printed with screen printing onto a TPU substrate.
The classic rigid circuit board built measurement and communication unit are then
attached onto the connector points of the layout. Finally, the substrate is laminated
3.1. The Patient Site 32
onto the fabric face down to avoid interferences and distortions through the patients
body. The electrodes, however, are turned up-side-down, in order to provide contact
with the skin.
Figure 3.4 The design of the printed electronics utilized in the architecture. The shown
design is not the final version, as this contains confidential parts and cannot be used in
public work at the moment.
Figure 3.4 shows a version of the screen printed electronics used in the concept. As
the final design contains confidential parts, it cannot be used in public work at the
moment. The shown layout still provides a good idea of what the electronics will
look like. The dimensions of the layout are: 164 mm by 215 mm. The larger areas
are the electrodes that are in contact with the patients skin and used to record the
ECG and the bio-impedance. Their diameter is 25 mm.
The smaller star like structures are the connector areas, where the measurement
unit, the wireless communication unit and the power source will be placed. The
external units will be connected with a bio-compatible, conductive glue that has to
withstand washing, as the t-shirt, has to be cleaned. As this is a proof-of-concept
work, the design should at least with-stand hand washing.
3.1. The Patient Site 33
3.1.2 Measurement Unit
The measurement unit, which is a classic rigid substrate ciruit board with surface
mounted resistors and capacities, will incorporate the Texas Instruments Inc. (TI)
ECG and bio-impedance measurement chip ADS1292R [60]. As for the proof-of
concept system a non-rechargeable coin cell battery will power the whole application.
The power source will be included on another external module, which will not be
described closer in this work. Currently, Katariina Tuohimäki is working on a Master
Thesis to closer investigate the ADS1292R and its incorporation in the architecture.
Figure 3.5 A rendered version of the printed circuit board (PCB) that incorporates the
TI ADS1292R and other passive components.
Figure 3.5 shows a rendered version of the (rigid) printed circuit board (PCB) that
incorporates the ADS1292R and needed passive components. The diameter of this
board is 19 mm, which is about as large as a 10 Eurocent coin. All of the used
components are surface mounted to save space, which is important for the minia-
turization in these applications. After the mounting of the components the whole
layout can be polymer coated, or placed in encasing in order to provide protection
of the sensitive electronics.
The TI ADS1292R is a 3-channel 24-bit analog-to-digital converter (ADC), specif-
ically designed for the utilization in medical applications. It is equipped with a
built in functionality for ECG and respiratory BI measurements. It needs a supply
voltage between 2.7 and 5.25 V. The chip uses only 335 µW per channel that is
used in the application, totaling at a 1.005 mW for the whole application. This
3.1. The Patient Site 34
low energy consumption makes it the choice for this architecture, because it enables
the planned long term functionality of the system on a small power source. Also
included in the chip is a 50/60Hz filter to exclude distortions through the general
land line AC. The chip itself measures 5 x 5 mm including the leads and is advised
to be operated between -40 and 85 C [60]. Furthermore, the chip adds another
functionality to the system, as it incorporates a three dimensional accelerometer.
The ECG measurements are to be done with the standard 500 Hz sampling fre-
quency, as the BI measurement is run at 125 Hz. These frequencies should suffice
for the planned data processing and provide a high-enough resolution. As of now,
there is no decision on the sampling rate of the accelerometer values. Given the
values of ECG and BI, a multiple of 125 Hz would be most sensible. The ECG
sampling rate can even be lowered to 250 Hz, in order to not produce too much
data. This is another crucial aspect of a mobile monitoring application in order to
save energy, due to fewer transmissions, because of less data.
3.1.3 Wireless Communication Unit
The wireless communication unit utilizes Bluetooth Low Energy. The modules’
center is the Texas Instruments CC2540 chip that is incorporated in the Bluegiga
BLE112 Bluetooth Smart Module. Using an low-energy module is essential in a
mobile longterm measurement system, as stated earlier. In figure 3.6 the wireless
communication unit is shown in total, in the middle the BLE112 module by Bluegiga
[61, 59].
Figure 3.6 A low energy Bluetooth module with compact measurements is soldered onto
a PCB.
3.1. The Patient Site 35
The BLE112 module measures 18.10 x 12.05 x 2.3 mm, which makes it a very
fitting part of the system, where small parts are needed in order to not discomfort
the patient. The very low current consumption of 36 mA in stand-by and 0.4
µA while sending data made this module the choice for the testing system, as the
provided energy has to be mobile, and therefore small, as possible [61]. The module
is incorporated in a waterproof and bio-compatible shell that includes conductive
connectors on the bottom side which are connected to the printed electronics with
a conductive glue. The finished module measures about 25mm in diameter (about
the size of a 2 Euro coin).
The BLE112 has an integrated micro processor, which makes it possible that the
recorded data is collected and packed into a ASCII table format that can be read
by the mobile gateway unit. The table should contain following information:
Time stamp
ECG lead II measurement values
Bio-impedance measurement values
The composition of the table in ASCII format should lead to a overview that looks
like table 3.1. The time stamp has the format YYYY-MM-DD HH:MM:SS:mSmSmS
in order to control the correct sampling of the signals. The two bio-signal should be
read and saved as accurate as necessary and as small as possible, in order to save
transfer time. The accelerometer values for each axis will also be included into this
table in the same manner on the right hand side.
3.1.4 Mobile Gateway
The mobile Gateway will be (as well as the server structures) provided by Elisa Oy.
In the case of this architecture it is a smart phone running Android OS in a not
further stated version. The mobile phone is connected via Bluetooth Low-Energy
to the wireless communication unit and receives the measured data as packages in a
defined interval. This is to reduce the amount of energy used with these connections:
package sending is more energy efficient than a continuous data stream. The smaller
the defined interval is, the smaller the sent packages can be.
3.2. The Server Site 36
Table 3.1 Example table that should be created by the BLE112 before sending the data to
mobile gateway
time stamp (500 hz) ecg (500 hz) bi (125 hz)
2016-09-22 16:47:08.128 0.736 5.234
2016-09-22 16:47:08.130 0.744
2016-09-22 16:47:08.132 0.752
2016-09-22 16:47:08.134 0.756
2016-09-22 16:47:08.136 0.756 5.689
2016-09-22 16:47:08.138 0.780
2016-09-22 16:47:08.140 0.768
2016-09-22 16:47:08.142 0.760
2016-09-22 16:47:08.144 0.712 5.347
An application in the background regulates the connection with the communication
unit. The recieved packages are unpacked into a data file that contains the same
information, but recombined. This application also sends newly packed, bigger
packages (chucks) of data via the GPRS connection to a server.
3.2 The Server Site
After the data has been acquired, it will be sent from the mobile gate way to the
server. This represents another major part of the architecture. On the server data
processing and analysis will happen, as well as data storage. For the aimed proof-
of-concept system, the storage will be reduced to a minimum, that can be used
for testing purposes. In Chapter 4 possible and necessary enhancements will be
suggested, which are focusing on the reduction of processing power.
Server Site
Data
Storage
Layer 4
Data
Processing
Layer 5
Figure 3.7 The server has two general functions in the architecture: data processing and
data storage. For a larger image, in relation to the other sites, check Appendix A at page
54
3.2. The Server Site 37
In the following sections suggestions for a staged storage are made and the planned
data processing aims are described. For the DISSE project Elisa Oy will provide
the needed servers.
3.2.1 Data Processing and Analysis
With the data arrived on the server the processing of it has to happen in order
to obtain crucial parameters for the patient’s status. Very often those are a huge
number of parameters, especially for ECG measurements. However, to reduce the
processing power, the most common and useful ones are selected for the proof-of-
concept system. Later more complex and processing intensive algorithms can be
added. At the moment of writing of this thesis Shadi Mahdiani is investigating
these processes and their function closer. She will present the results of this in her
own Master Thesis, created in Tampere University of Technology.
Most important before any kind of parameter search is a filtering method that
excludes the parts of the signals that are not usable for analysis. This means that
at least bandpass filtering and other noise reduction techniques are applied on the
signal before further processing.
Important to any ECG analysis is the detection of the R-peak. Different methods
for that are in the discussion momentarily and no final choice has yet been made
for the prototype system. Aiming for further anomalies that can be detected in
the ECG, an ectopic beat detection method is also in development. With those
methods, parameters like: Heart Rate or its variability are calculated and give a
deeper insight in the status of the patient. Not only the R-peak is important for
the analysis of the heart condition, but also other parts of the ECG can be used
for further investigation. For example, the ST-segment can give insights about
myocardial infarction or coronary ischemia depending on its elevation or slope.
As for the EIP, the most common used method, again, is the peak detection. With
the detected peaks in the signal the easiest parameter to determine is the breathing
frequency. As well, with the amplitude of the signal, it can be measured how deep
the patient is actually breathing and whether or not he/she might be under supplied
with oxygen.
3.3. The User Site 38
3.2.2 Data Storage
Generally spoken, the recorded data will be secured first on the storage available on
the server for further processing. A staged stored system is, however, needed, since
not all the data can be kept. Not neglecting ’unimportant’ data leads to a mass of
accumulated records, that not only are highly unlikely to be useful, but also slow
down the processing power of the server.
In order to reduce the amounts of stored data the, mentioned, staged system is
introduced. Staged means in this case that older data is compressed by averaging
the values of:
one hour for the last 48 hours
one day for the last 14 days
one week for the last 3 months
one month for the last 2 years
Of course, to realize this an algorithm has to scan and compress said storage data.
This will require more computational power, but is essential to not slow down the
other processes. The compressing can be done once per hour to keep the processing
load to a minimum. This will enable the medical personnel to review a trend of the
patients status within a reasonable time frame for most conditions, yet save storage
space.
If found in the prototype testing phase that those compressed values are too low
or too high they are able to be altered for further testing. Again, different medical
conditions can ask for appropriate settings.
3.3 The User Site
The user site is represented by the graphical interface on which the users can view
the visualized data and the user profiles. As opposite to the patient site, the below
mentioned patient profile has nothing to do with the hardware. This section focuses
purely on the user profiles, which are used to access the data which is stored on the
3.3. The User Site 39
User Site
Graphical User Interface
Layer 6
User Profiles
Layer 7
Medical
Sta
Patient
Medical
Professional
Figure 3.8 The user site is represented by the graphical interface for visualized data and
the user profiles. For a larger image, in relation to the other sites, check Appendix A at
page 54
server, and the visualization of said data in a graphical user interface. Figure 3.2
shows those two parts of this sector in the architecture.
Because this thesis is here to describe the architecture and not to provide the func-
tional prototype, only suggestions are made in the following sections. For the design
of a graphical interface the help of a professional industrial designer might be ad-
vised. The described procedures here, normally happen in the earlier described IoT
platform. There profiles can be created that allow only certain access to defined
user groups, so called user profiles or roles. As well the graphical interface is built
in these platforms.
3.3.1 User Profiles
IoT Platforms always allow to create different user groups with distinct access rights.
This should be utilized in the architecture as to define which user group has access
to which part of the data. In general, there need to be three user profiles defined:
1. Patient Profile
2. Medical Personnnel Profile
3. Medical Professional Profile
3.3. The User Site 40
Each of which bares the access rights suitable for the individual group of users. In
the following section user rights are discussed in more detail and the possibilities of
each profile are shown closely. Each profile has its own reading and writing access
rights.
The profiles are secured with passwords for each created user account. The accounts
have different roles attached to them, which are defined at the accounts creation
through a system administrator.
Patient Profile
The patient profile enables the patient to see his/her own data. This profile is mainly
used for self control. It is intended to just present the data history, so that he/she
can check, when interested.
The patient may check on the provided smart phone via the application or the
browser based interface after a login process. Since the interface is browser based a
standard computer could also be used to login and view the information. However,
this profile is not able to access all information stored on the server. Generally, the
patient can view his current heart rate and respiration rate. Maybe a trend overview
of the last days can be included.
Opposite to the other profiles the patient one is not able to change or add any medical
important information. However, it is crucial to give the opportunity to patients
to add feedback or information into their data-file. This not only gives a feeling of
security and importance towards the patient, but also can provide information to
the personnel and doctors.
Medical Personnel Profile
Usually the personnel having most contact with the patient are nurses. To provide
important information about the patients’ status this user profile gives all measured
and calculated parameters.
Additional to access to the current status, the personnel is able to access the medical
history of the patient, for as long as he has been using the wearable tele-medicine
3.3. The User Site 41
system. A possible interface for the access is described a little later.
As well as the patient, the personnel is able to add information about the status.
However, this profile is able to annotate the data in order to mark incidents or
important events, which should be double checked by the medical professional.
Medical Professional Profile
The difference between the personnel and the medical professional is that the latter
is able to add diagnostic information to the patients’ data file. Otherwise the general
functionality between these profiles are the same. To provide more information for
the doctors, this profile is also able to access the whole medical history of the patient.
For this functionality a standardized medical record keeping is necessary, in order
to view it correctly.
3.3.2 Graphical User Interface - GUI
Generally, at least two different interfaces are needed: One for a mobile platform
and one for a computer based platform with a larger screen area. This is important
in order to ensure an appealing interface for users accessing the data from different
platforms. In figure 3.9 ideas for those GUIs are presented.
DISSE Prototype Desktop
Patient Information
ID Number:
Last name:
First name:
Gender:
Date of Birth:
Adress:
Height:
Weight:
Latest Alarms:
Comments
Current Heart Rate
67
b/min
Heart Rate last 24 h
Current Respiratory Rate
12
1/min
Respiratory Rate last 24 h
Please enter your comments here … |
Patient Picture
Current Heart Rate
67
b/min
Heart Rate last 24 h
Current Respiratory Rate
12
1/min
Comments
DISSE Prototype App
Please enter your comments here … |
A) B)
Figure 3.9 The Graphical User interface should be accessible on different platforms,
therefore two versions are needed: A) Desktop Version and B) Mobile Version.
3.3. The User Site 42
Where the mobile interface should only contain basic information, about the mo-
mentary status, the desktop interface gives access to the full picture.
Visible in the mobile interface are the current heart rate (calculated on the server
for the e.g. last 5 minutes), the breathing frequency, total steps for the calender
day and a overview of the heart rate trend in the last 24 hours. A comment field
provides the possibility to add information.
On the other side, the desktop application ((A) in figure 3.9) provides more informa-
tion about the patient. After a login and patient selection, a panel shows the basic
information about the patient that have been entered at acceptance. Again, current
heart rate and respiratory rate show the lastest status. Trend lines and history of
chosen parameters can be displayed as well. Logos at the bottom corner mark the
developer, the DISSE project and their partners. A patient profile picture might be
used for easier identification. A field with the latest alarms shows all recent alarms
applicable for that patient.
The mobile application ((B) in figure 3.9) is mainly intended for short overview and
can be used by all three user profiles. However, the desktop application is intended
only for usage by the medical personnel and doctors. On start of the applications
the user is asked for his/her account credentials, on the entering of which the main
screen is displayed. Depending on the profile, the person has different viewing or
writing permissions, as described earlier.
43
4. DISCUSSION
4.1 Design Flaws and Problems
Starting with more general flaws this chapter will also discuss more specific ones
that the individual parts can have. The system as describe above is designed to
be able to assemble a proof-of-concept prototype containing all the elements. It
has been designed with the future in mind, so that modular part can be added to
increase the architectures’ capabilities.
As possible flaw of any mobile system the batteries have to be named. Every part of
an electrical measurement system has to be provided with electricity and is useless
if the batteries run out. Therefore, any alterations of the architecture has to be
made with the power consumption in mind. All the single devices have constantly
be monitored to not run out of battery. They have to be charged or the batteries
have to be replaced, which produces a new challenge on how to design a user friendly
and reliable charging system.
This system is designed with the freedom from cables to make the usage more
comfortable for the patient and the medical personnel. This leads to the problems
that wireless technologies still possess. The Bluetooth has only a short range where
it can reliably transfer data between the devices. Therefore, it is a necessity that the
patient has the mobile gateway always close by. In case of a smart phone the biggest
problem might be that it can be forgotten, which makes this not only a technical,
but also a human fault based, design flaw.
Looking at the wearable piece of clothing that incorporates the printed electrodes;
To produce any usable electrical bio-signal, the electrodes need to remain in constant
contact with the patients’ skin, since the observed signal changes depending on the
electrodes’ locations. This cannot be ensured with the idea that this system is
designed with. The step away from attached electrodes provides most likely the
hardest challenge in the realization of this project. To ensure a relatively good
4.2. Future Outlook 44
contact with the skin and also fewer detachments, the shirt has to be quite tight
fitting, this can make it uncomfortable to wear. Motion artifacts can cause a problem
for the signal processing and analysis part that have to ensure correct filtering and
treatment of such distortions. Additionally the shirt has to be able to be washed at
high temperatures to ensure aseptic status.
As for this project the ThingWorx IoT platform by PTC was intended, but turned
out to be far too complex for actual use in the prototype. Instead more reasearch
has to be put into this. Candidates for the applicable platforms should be the open
source structure of Kaa or the generally free Amazon Web Services. Those will not
include the server storage or processing power, but neither does Thingworx. As for
this project Elisa Oy will provide the needed servers.
Also, none of the mentioned IoT platforms has a Matlab compatibility, which is
somewhat important for the DISSE project, since the data processing is done in
said program. That means that the data has to be collected, exported, evaluated
and imported back into the platform. This completely, will disable a ’real-time’
functionality of any IoT platform.
4.2 Future Outlook
As the thesis thrives to provide the best possible base for a telemedicine system that
utilizes IoT platform and is expandable for future use, the following parts will focus
on what to include in a further development.
4.2.1 Software Enhancing
Adding more user profiles. For example the relatives of the patient should be able
to check on him via a ’visitors/relatives/family’ user profile and be able to see latest
general changes. Also a face-to-face video conference with the patient and the doctor
via a secure communication line could be included.
A very important part of the future system is the data storage of the medical records.
Not only has the data format already to be considered now in the development, but
also it is necessary to face future developments in regard to formats of medical record
keeping. The system as it is right now may store some essential information, but
for further development a standard has to be integrated in the architecture.
4.2. Future Outlook 45
The most important next step for the software development, however, will be to
implement an alarm system, which already operates on the gateway device level. In
case of heart failure, breathing complications or a sudden fall, an alarm has to be
triggered right on the gateway, without sending the data first to the server to be
analyzed. To do that general, very specific data processing algorithms already have
to be implemented into the gateway software.
4.2.2 Hardware Enhancing
Not only the software has to be considered when integrating more functions in the
future, but especially the hardware part can be enhanced as well, more sensors can
help assessing more data and give detailed information about the patients status.
Sensors
As far as the sensors go, there is basically limitless possibilities. Adding more phys-
iological signals that can be directly recorded from the body is a matter of the
utilization of the printed electronics and their connections. For example accelerom-
eters can be used for the number of steps or the general movement, as in commercial
available wearables. The motion data can be used to assess the physical activity of
the patient.
An implemented Global Positioning System (GPS) module, or the location data
from the smart phone can be used to locate the patient, in case he/she is outside of
the facility, e.g. on a walk. This data could be used in case of emergencies to locate
the patient and send an ambulance directly to the location, without waiting for a
third party to call and ask for assistance.
Ambient sensoring can be introduced in a later stage. This means that more than
just vital parameters are being monitored. Certain signals might just be usable for
evaluation of the health stage of a patient. Incorporating a sensitive element in the
fridge might allow to track the eating behavior of the patient.
4.2. Future Outlook 46
Buffer Storage
To ensure a gap-less recording that enables more meaningful diagnostics, a buffer
storage should be included into the architecture design. The buffer storage should
be as large to keep recorded data from at least 24hours. This should be used to
ensure that no data is lost during the longterm usage of the system.
47
5. CONCLUSION
It can be stated that the aim of this work, to describe the architecture for a proof-
of-concept measurement system that utilizes IoT structures and printed electronics,
has been achieved. With this, the motivation for creating a new approach to tele-
medical systems can be satisfied. To support further improvement of the treatment
landscape is just but one thing, someone can achieve to help people recover from
their illnesses and unwell-being.
This work finds relevance in the surroundings of other described tele-medical ar-
chitectures by incorporating a new aspect. The conceptual layer structure of an
Internet of Things application, which was described by Cicso Systems can be mod-
eled onto all parts of this architecture. This furthermore proves that basically any
modern tele-medical system, which utilizes wearable technology, can be mapped
onto this layer concept.
The biggest challenge in creating this work was the communication with all involved
parties and introducing their needs and wants in this thesis. Nevertheless, the base
framework for all DISSE researchers is now fully described and feedback already
showed that it was very helpful for fellow researchers to find out what happens
before or after their respective subproject. It was interesting to see that there is
a general direction of development for government based medical record databases
and a fair amount of consistency throughout European countries.
Lastly, a definitive remark can be made by stating that the future development of
tele-medicine will definitely involve more wireless connected devices. Also, incorpo-
rating smart devices is a direction in which the technology heads. Furthermore, will
the artificial intelligence find its way sooner or later into this sector of technology.
With the innovation of startups, as well as the research done in major companies
an interconnected health care system might not be too far.
48
REFERENCES
[1] B. Walker. (2015, April) Every day big data statistics – 2.5 quintillion
bytes of data created daily. [Online]. Available: http://www.vcloudnews.com/
every-day-big-data-statistics-2-5-quintillion-bytes-of-data-created-daily/
[2] F. A. F. Marques, D. M. D. Ribeiro, M. F. M. Colunas, and J. P. S. Cunha, “A
real time, wearable ecg and blood pressure monitoring system,” 6th Iber. Conf.
Inf. Syst. Technol., pp. 1–4, 2011.
[3] E. J. Topol. (2015, Jan) The future of medicine is in
your smartphone. [Online]. Available: http://www.wsj.com/articles/
the-future-of-medicine-is-in-your-smartphone-1420828632
[4] American Telemedicine Association. (2012) What is telemedicine.
[Online]. Available: http://www.americantelemed.org/about-telemedicine/
what-is-telemedicine#.Vwz46mNQ5SU
[5] R. K. C. Hsieh, N. M. Hjelm, J. C. K. Lee, and J. W. Aldis, “Telemedicine
in China,” International Journal of Medical Informatics, vol. 61, no. 2-3, pp.
139–146, 2001.
[6] G. Angius, D. Pani, L. Raffo, P. Randaccio, and S. Seruis, “A tele-home care
system exploiting the DVB-T technology and MHP,” Methods of Information
in Medicine, vol. 47, no. 3, pp. 223–228, 2008.
[7] L. Duan, W. N. Street, and E. Xu, “Healthcare information systems: data
mining methods in the creation of a clinical recommender system,” Enterprise
Information Systems, vol. 5, no. 2, pp. 169–181, 2011.
[8] R. Bellazzi, S. Montani, a. Riva, and M. Stefanelli, “Web-based telemedicine
systems for home-care: Technical issues and experiences,” Computer Methods
and Programs in Biomedicine, vol. 64, no. 3, pp. 175–187, 2001.
[9] O. S. Adewale, “An internet-based telemedicine system in Nigeria,” Interna-
tional Journal of Information Management, vol. 24, no. 3, pp. 221–234, 2004.
[10] C.-S. Wang, “The Implementation of a Tele-Homecare System with Service
Oriented Architecture and HL7 Message Transmission Standard,” American
REFERENCES 49
Journal of Public Health Research, vol. 1, no. 1, pp. 18–26, 2013. [Online].
Available: http://pubs.sciepub.com/ajphr/1/1/3/index.html
[11] N. S. Gehlot, “State-of-the-Art of Mobile-Health: Technology, Sensors and
Clinical Applications,” Journal of Communication and Information Technol-
ogy, vol. 2, no. 1, pp. 20–24, 2012.
[12] J. H. van Bemmel, M.A. Musen, Handbook of Medical Informatics. Springer
Berlin Heidelberg, 1997. [Online]. Available: https://books.google.fi/books?
id=tLjqnQEACAAJ
[13] E. Kaniusas, “Fundamentals of Biosignals,” in Biomedical Signals and Sensors.
Heidelberg: Springer-Verlag, 2012, ch. 1, pp. 1–21.
[14] E. N. Marieb, K. Hoehn, Human Anatomy & Physiology, 8th ed., S. Beaupar-
lant, Ed. Pearson Learning Solutions, 501 Boylston Street, Suite 900, Boston,
MA 02116: Benjamin Cummings, 2010.
[15] R. E. Klabunde. (2016, March) Cardiovascular physiology concepts. [Online].
Available: http://www.cvphysiology.com/Arrhythmias/A013.htm
[16] J. D. Trigo, Á. Alesanco, I. Martínez, and J. García, “A review on digital ECG
formats and the relationships between them,” IEEE Transactions on Informa-
tion Technology in Biomedicine, vol. 16, no. 3, pp. 432–444, 2012.
[17] A. F. Pacela, Impedance pneumography—A survey of instrumentation
techniques,” Medical and biological engineering, vol. 4, no. 1, pp. 1–15, 1996.
[Online]. Available: http://dx.doi.org/10.1007/BF02474783
[18] K. R. Foster, H. C. Lukaski, “Whole-body impedance - what does it measure?”
The American Journal of Clinical Nutrition, vol. 64, pp. 388S – 396S, 1996.
[19] J. Freeman, M. Lalli, “Impedance Measuring Devices and Methods for Emer-
gency Cordivascular Care,” U. S. Patent US2013/0023781A1, 24 Jan., 2013.
[20] A. K. Gupta, “Respiration Rate Measurement Based on Impedance Pneumog-
raphy,” Texas Instruments Inc., Tech. Rep. February, 2011.
[21] T. Someya, Stretchable Electronics. Wiley, 2013.
[22] D. Saff, D. Sacilotto, Screenprinting: History and Process. New York: Holt,
Rinehart and Winston, 1979.
REFERENCES 50
[23] J. Suikkola, “Printed Stretchable Interconnects for Wearable Health and Well-
being Applications,” Masterthesis, Tampere University of Technology, 2015.
[24] A. Hobby. (1997, March) Printing thick film hybrids. [Online]. Available:
http://www.gwent.org/gem_thick_film.html
[25] Bluetooth Special Interest Group, Inc. (2016) Bluetooth. [Online]. Available:
https://www.bluetooth.com/what-is-bluetooth-technology/bluetooth
[26] Bluetooth Special Interest Group, Inc. (2016) Bluetooth technology basics. [On-
line]. Available: https://www.bluetooth.com/what-is-bluetooth-technology/
bluetooth-technology-basics
[27] IAS Discussion. (2015, May) How does bluetooth work? [Online]. Available:
http://www.iasdiscussions.com/general-science/how-does-bluetooth-work/
[28] Bluetooth Special Interest Group, Inc. (2016) Profiles overview. [On-
line]. Available: https://developer.bluetooth.org/TechnologyOverview/Pages/
Profiles.aspx
[29] M. Idžan. Mobile communications in brief. [Online]. Available: http:
//www.slideshare.net/midzan21/mobile-communications-38154321
[30] A. Huurdeman, The Worldwide History of Telecommunications, ser. A
Wiley-interscience publication. Wiley, 2003. [Online]. Available: https:
//books.google.fi/books?id=SnjGRDVIUL4C
[31] WorldTimeZone.com. (2016, April) Gsm world coverage map and gsm country
list. [Online]. Available: http://www.worldtimezone.com/gsm.html
[32] E. Dahlman, S. Parkvall, J. Skold, and P. Beming, 3G Evolution: HSPA and
LTE for Mobile Broadband, ser. 3G Evolution Series. Elsevier Science, 2010.
[Online]. Available: https://books.google.fi/books?id=cmMgp4j23D0C
[33] K. Tehrani, M. Andrew. (2014, March) Wearable technology and wearable
devices: Everything you need to know. [Online]. Available: http:
//www.wearabledevices.com/what-is-a-wearable-device/
[34] S. Frey. (2016, Feb) What is wearable technology, and which stocks dominate
the space? [Online]. Available: http://www.fool.com/investing/general/2016/
02/08/what-is-wearable-technology-and-which-stocks-domin.aspx
REFERENCES 51
[35] Polar Electro Oy. (2016) Heart rate monitors, fitness trackers, and gps sports
watches. [Online]. Available: https://www.polar.com/uk-en/products
[36] Fitbit Inc. (2016) Fitbit official. [Online]. Available: http://www.fitbit.com/fi/
home
[37] General Electric Company. (2015) The future of
health tech: How wearables could transform pa-
tient care. [Online]. Available: http://newsroom.gehealthcare.com/
the-future-of-health-tech-how-wearables-could-transform-patient-care/
[38] S. Kosir. (2015, April) Wearables in healthcare. [Online]. Available:
https://www.wearable-technologies.com/2015/04/wearables-in-healthcare/
[39] Health Care Originals. (2016) Health care originals official. [Online]. Available:
http://healthcareoriginals.com
[40] B. Wang. (2014, October) The internet of things world forum unites
industry leaders in chicago to accelerate the adoption of iot business
models. [Online]. Available: http://www.marketwired.com/press-release/
internet-things-world-forum-unites-industry-leaders-chicago-accelerate-adoption-iot-nasdaq-csco-1957407.
htm
[41] D. Gualtieri. (2013, October) The internet of things. [Online]. Available:
http://tikalon.com/blog/blog.php?article=2013/Internet_of_things
[42] Intel Corporation, “Transforming Healthcare with Telemedicine Solutions based
on the Internet of Things ( IoT ),” Tech. Rep., 2014.
[43] PTC. (2016) Iot solutions for medical device manufacturers. [Online]. Available:
http://www.thingworx.com/Markets/Medical-Devices
[44] CyberVision, Inc. (2016) Kaa iot platform overview. [Online]. Available:
http://www.kaaproject.org/overview/
[45] Amazon Web Services, Inc. (2016) Aws iot. [Online]. Available: https:
//aws.amazon.com/iot/?hp=tile
[46] Deloitte, “Networked medical device cybersecurity and patient safety: Perspec-
tives of health care information cybersecurity executives,” 2013.
REFERENCES 52
[47] United States Government Accountability Office, FDA Should Expand
Its Consideration of Information Security for Certain Types of Devices,”
Tech. Rep. August, 2012. [Online]. Available: papers3://publication/uuid/
88F7C310-93E4-41DE-801E-31C7F173002A
[48] U.S. Food and Drug Administration. (2013, June) Cybersecurity for medical
devices and hospital networks: Fda safety communication. [Online]. Available:
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm356423.htm
[49] Department of Health and Human Services, “Health Insurance Reform:
Security Standards; Final Rule,” Tech. Rep. 34, 2003. [Online]. Available:
http://federalregister.gov/a/03-3877
[50] W. H. Maisel and T. Kohno, Improving the security and privacy of
implantable medical devices.” The New England journal of medicine, vol. 362,
no. 13, pp. 1164–6, 2010. [Online]. Available: http://www.ncbi.nlm.nih.gov/
pubmed/20357279
[51] U.S. Food and Drug Administration, “Content of premarket submissions for
management of cybersecurity in medical devices,” Tech. Rep., 2014.
[52] Lucid Software Inc. (2015) Activity diagram. [Online]. Available: https:
//www.lucidchart.com/pages/uml/activity-diagram
[53] D. Halperin, T. S. Heydt-Benjamin, K. Fu, T. Kohno, and W. H. Maisel, “Secu-
rity and Privacy for Implantable Medical Devices,” IEEE Pervasive Computing,
vol. 7, no. 1, pp. 30–39, 2008.
[54] INTERNATIONAL ELECTROTECHNICAL COMMISSION, “IEC 62304
Medical device software – Software life cycle processes, preview version,”
Tech. Rep., 2006. [Online]. Available: https://webstore.iec.ch/preview/
info{_}iec62304{%}7Bed1.0{%}7Den{_}d.pdf
[55] R. Mann and J. Williams, “Standards in medical record keeping.” Clinical
medicine (London, England), vol. 3, no. 4, pp. 329–32, 2003. [Online].
Available: http://www.ncbi.nlm.nih.gov/pubmed/12938746
[56] H. Hietala. (2009, May) Feelgood – terveystaltioekosysteemi. [Online].
Available: http://feelgood.vtt.fi/FeelGood_loppuraportti.pdf
REFERENCES 53
[57] P. A. H. Williams and V. B. McCauley, A Rapidly Moving Target: Confor-
mance with E- Health Standards for Mobile Computing,” in 2nd Australian
eHealth Informatics and Security Conference, 2013, pp. 40–49.
[58] Health Level Seven. (2016) Introduction to hl7 standards. [Online]. Available:
http://www.hl7.org/implement/standards/index.cfm?ref=common
[59] Bluegiga Technologies Limited. (2016) BLE112 Bluetooth Smart
Module. [Online]. Available: https://www.bluegiga.com/en-US/products/
ble112-bluetooth-smart-module/#buynow
[60] Texas Instruments, “Low-Power, 2-Channel, 24-Bit Analog Front-End for
Biopotential Measurements,” Datasheet, Dec. 2011. [Online]. Available:
http://www.ti.com/lit/ds/symlink/ads1292r.pdf
[61] Bluegiga Technologies Ltd, “BLE112 Data Sheet,” Datasheet,
2011. [Online]. Available: https://www.bluegiga.com/en-US/products/
ble112-bluetooth-smart-module/#login-modal
54
APPENDIX A - THE COMPLETE
ARCHITECTURE
User Site
Server Site
Patient Site
Printed Electronics Measurement unit
Layer 1
Wireless Communication
Unit
Layer 2
Mobile Gateway
Layer 3
Data
Storage
Layer 4
Data
Processing
Layer 5
Graphical User Interface
Layer 6
User Profiles
Layer 7
Bio-Signals
ECG
BI
Medical
Sta
Patient
Medical
Professional
Figure 1 The complete Architecture, which contains all 7 Layers of a IoT system. With
images from [20, 59].
... Fig. 20 delineates 3-layer architecture of IoT (Bing, 2016). Fig. 21 visualizes the 7-layer architecture of IoT (Tietz, 2016). This work has considered the most prominent and accepted 4-layer architecture (in Fig. 22). ...
Article
The IoT is the upcoming one of the major networking technologies. Using the IoT, different items or devices can be allowed to continuously generate, obtain, and exchange information. Different IoT applications nowadays are centered on computerizing various errands and are attempting to engage the inanimate physical items to act without direct supervision of a human. The current and forthcoming IoT services are exceptionally encouraging to build the degree of solace, proficiency, and automation for the clients. To obtain the option to actualize such a world in a continuously developing manner requires high security, protection, verification, and recuperation from assaults. Right now, incorporating the requisite changes in IoT systems engineering to achieve end-to-end, stable IoT infrastructure is paramount. In this research, a comprehensive analysis is incorporated into the security-relevant problems and threat wellsprings in IoT resources or applications. Specific that and current advancements based on maintaining a high degree of confidence in IoT apps are addressed while looking at the security issues. Four distinct developments are investigated, including cryptography, fog computing, edge computing, and ML (Machine Learning), to extend the degree of IoT security.
Article
Full-text available
Recommender systems have been extensively studied to present items, such as movies, music and books that are likely of interest to the user. Researchers have indicated that integrated medical information systems are becoming an essential part of the modern healthcare systems. Such systems have evolved to an integrated enterprise-wide system. In particular, such systems are considered as a type of enterprise information systems or ERP system addressing healthcare industry sector needs. As part of efforts, nursing care plan recommender systems can provide clinical decision support, nursing education, clinical quality control, and serve as a complement to existing practice guidelines. We propose to use correlations among nursing diagnoses, outcomes and interventions to create a recommender system for constructing nursing care plans. In the current study, we used nursing diagnosis data to develop the methodology. Our system utilises a prefix-tree structure common in itemset mining to construct a ranked list of suggested care plan items based on previously-entered items. Unlike common commercial systems, our system makes sequential recommendations based on user interaction, modifying a ranked list of suggested items at each step in care plan construction. We rank items based on traditional association-rule measures such as support and confidence, as well as a novel measure that anticipates which selections might improve the quality of future rankings. Since the multi-step nature of our recommendations presents problems for traditional evaluation measures, we also present a new evaluation method based on average ranking position and use it to test the effectiveness of different recommendation strategies.
Chapter
Sensing technologies in physiology gain a lot of importance for the assessment of the human functional state. The registered biomedical signals—referred to as biosignals here—are important not only for timeless classical applications concerning medical diagnosis and subsequent therapy, but also for future applications such as daily driver monitoring.
Article
The rapid advancement of Fourth Generation (4G) and Long Term Evolution (LTE) Wireless Technologies are set to revolutionize the healthcare system. The Mobile-Health (m- Health) platform integrates vital signs monitoring medical sensors based on Body Area Network (BAN); mobile processing, computing & retrieving using telecommunication technologies to provide medical services on demand anywhere. This review paper deals with Wireless Technologies, Body Area Networks, Wearable & Implantable Medical Sensors, and Medical Image retrieval focusing on concepts, systems and technologies for 4G Mobile Health.
Article
Telemedicine is a very exciting field worldwide. Nigeria has a population of more than 120 million people, a major percentage of which live in the remote rural areas, whereas with the best-equipped hospitals and scarce medical experts are distributed in the urban cities. These people living in remote rural and poorer areas have limited access to basic healthcare. Geographic isolation, the scarcity of physicians and hospitals, and difficulties of travel to larger cities where such care is available are among the factors limiting this access. Governments at federal, state and local levels, have been making healthcare in these remote rural areas their focal point over the years so as to enable citizens in both rural and urban areas to have equal access to medical services and clinical healthcare despite the geographic isolation barriers but this effort has only been partly successful. Therefore, establishment of an Internet-based telemedicine system would be most useful in achieving government's aims of bringing useful healthcare to these remote rural and poorer areas. This among other things would improve the quality of healthcare in rural and outlying areas, lower costs of delivering healthcare and give remotely placed physicians the opportunity to consult over any patient's case. In this paper, an Internet-based telemedicine environment is developed for Nigeria, specifically to support consultations among remotely placed patients, rural health workers and specialists in the urban cities and provide a secure access to remote patient records. The paper further discusses some of the challenges and implementation issues of telemedicine in Nigeria.
Article
The study of stress and fatigue among First Responders is a major step in mitigating this public health problem. Blood pressure, heart rate variability and fatigue related arrhythmia are three of the main "windows" to study stress and fatigue. In this paper we present a wearable medical device, capable of acquiring an electrocardiogram and estimating blood pressure in real time, through a pulse wave transit time approach. The system is based on an existent certified wearable medical device called "Vital Jacket" and is aimed to become a tool to allow cardiologists in studying stress and fatigue among first response professionals.