IMPROVING PREVENTION METHODS AND INNOVATING THE DANISH TELEMEDICINE INFRASTRUCTURE BY INTRODUCING A NEW MEDICAL PARADIGM Table of content Reading Instructions ........................................................................................................................................................... 5 Chapter 1............................................................................................................................................................................. 6 1.1 Introduction .................................................................................................................................................................. 6 1.2 Problem formulation ..................................................................................................................................................... 7 1.2.1 Initiating problem.................................................................................................................................................. 7 1.2.2 Supporting initiating problems .............................................................................................................................. 8 1.3 Methodology ................................................................................................................................................................. 8 1.4 Project management .................................................................................................................................................... 10 1.4.1 Why is it important to analyze Project Management? ........................................................................................ 10 1.4.2 Why are we together? ......................................................................................................................................... 11 1.4.3 Scheduling of Project .......................................................................................................................................... 11 1.4.4 Identifying Stakeholders ..................................................................................................................................... 15 1.5 Risk Management ....................................................................................................................................................... 15 Risk Management Plan ................................................................................................................................................ 15 1.5.1 Risk Identification .......................................................................................................................................... 16 1.5.2 Risk Quantification (probability and consequences) ...................................................................................... 16 1.5.3 Risk Response ................................................................................................................................................ 17 1.5.4 Risk Control ................................................................................................................................................... 18 Chapter 2........................................................................................................................................................................... 19 2.1 Introduction to telemedicine ....................................................................................................................................... 19 2.1.1 What drives telemedicine forward? .................................................................................................................... 21 2.1.2 Current projects in Denmark ............................................................................................................................... 21 2.1.3 Idea screening/idea evaluation ............................................................................................................................ 22 2.2. Model of what TeleMed can do ................................................................................................................................. 22 2.2.1 Features of TeleMed ........................................................................................................................................... 24 2.2.2 Blood pressure test .............................................................................................................................................. 24 2.2.3 Pulsoxymeter....................................................................................................................................................... 25 2.2.4 Eye vision test ..................................................................................................................................................... 25 2.3 Interviews ................................................................................................................................................................... 26 2.3.1 Interview A – Lung specialist ............................................................................................................................. 26 2.3.2 Interview B – Blood specialist ............................................................................................................................ 27 2.3.3. Interview C – Telemedicine scientist ................................................................................................................. 28 2.3.4. E-mail conversations .......................................................................................................................................... 28 2.4 Results of questionnaire overview .............................................................................................................................. 29 2.4.1 Locations: Reasons and obstacles ....................................................................................................................... 30 Chapter 3........................................................................................................................................................................... 39 3.1 Introduction to our infrastructural ideas...................................................................................................................... 39 3.2 Financial infrastructure ............................................................................................................................................... 40 3.2.1 Transaction costs ................................................................................................................................................. 40 2 3.2.2 Pilot Study........................................................................................................................................................... 42 3.2.3 Cost of final launching ........................................................................................................................................ 44 3.2.4 Investors .............................................................................................................................................................. 44 3.3 Human infrastructure .................................................................................................................................................. 45 3.4 Change Management .................................................................................................................................................. 46 3.4.1 Clarifying needs of different management groups .............................................................................................. 47 3.4.1.1 CAB ............................................................................................................................................................ 47 3.4.1.2 RFC ............................................................................................................................................................. 48 3.4.1.3 The final procedure ..................................................................................................................................... 48 3.4.2 Setting up different scenarios and needs of change ............................................................................................ 50 3.4.2.1 Change scenario: Blood chip ....................................................................................................................... 50 3.4.2.2 Change scenario: Legislation change .......................................................................................................... 51 3.5 Service Desk ............................................................................................................................................................... 52 3.6 Security ....................................................................................................................................................................... 54 3.6.1 Design and analysis of information systems – using XML as a unifying language ............................................ 54 3.6.2 Security requirements for Electronic Health Records ......................................................................................... 58 3.6.2.1 Access rights, availability and integrity ...................................................................................................... 58 3.6.2.2 Current situation of EHR in Denmark ......................................................................................................... 60 3.6.3 Object oriented programming security for web based applications .................................................................... 60 3.6.3.1 Three tier architectural approach: Client server database ............................................................................ 64 3.7 Standards/Legislation ................................................................................................................................................. 65 3.7.1 Standards that matter today ................................................................................................................................. 66 3.7.1.1 Fitting legislation in the infrastructure ........................................................................................................ 66 3.7.1.2 Legislation that matters today ..................................................................................................................... 67 3.7.1.3 Changes needed for our machine to be launched ........................................................................................ 68 Chapter 4........................................................................................................................................................................... 70 4.1 Comparison of StayHealthy ........................................................................................................................................ 70 4.2 Worldwide technical aspects related to TeleMed ....................................................................................................... 71 4.2.1 The French System ............................................................................................................................................. 72 4.2.2 The Swedish System ........................................................................................................................................... 72 4.3 Lung test ..................................................................................................................................................................... 73 4.4 RFID-patches .............................................................................................................................................................. 75 4.5 Blood Tests ................................................................................................................................................................. 78 4.6 Realistic future changes .............................................................................................................................................. 80 4.6.1 Iris laser test ........................................................................................................................................................ 80 4.6.2 Blood chip ........................................................................................................................................................... 81 4.6.3 Information offerings .......................................................................................................................................... 83 4.7 Differentiation of the market ...................................................................................................................................... 83 Chapter 5........................................................................................................................................................................... 85 5.1 Interest shown in TeleMed ......................................................................................................................................... 85 5.2 Distributor ................................................................................................................................................................... 86 3 Chapter 6........................................................................................................................................................................... 89 Conclusion ................................................................................................................................................................... 89 7.Bibliography .................................................................................................................................................................. 90 8.Attachments ................................................................................................................................................................... 96 Attachment 1: Questionnaire ....................................................................................................................................... 96 Attachment 2: Venture Cup leaflet .............................................................................................................................. 98 Attachment 3 : TELEKAT leaflet.................................................................................................................................101 List of Figures Figure 1: How to improve the general health in Denmark? ................................................................................................ 7 Figure 2: Problem solving model........................................................................................................................................ 9 Figure 3: Tasks for accomplishing a project ..................................................................................................................... 10 Figure 4: Gantt chart ......................................................................................................................................................... 14 Figure 5: Stakeholders of the project ................................................................................................................................ 15 Figure 6: Risk control ....................................................................................................................................................... 18 Figure 7: TeleMed machine capabilities ........................................................................................................................... 23 Figure 8: Age categories ................................................................................................................................................... 29 Figure 9: Location............................................................................................................................................................. 34 Figure 10: Usage of the machine ...................................................................................................................................... 34 Figure 11: Which tests ...................................................................................................................................................... 35 Figure 12: Trust in technology.......................................................................................................................................... 36 Figure 13: Doctor's visits .................................................................................................................................................. 37 Figure 14: Comparison of Usage of the machine and doctors visit .................................................................................. 38 Figure 15: New relationship doctor – patient.................................................................................................................... 45 Figure 16: Change management for TeleMed .................................................................................................................. 49 Figure 17: Entities involved in the development of RFC’s............................................................................................... 49 Figure 18: Decision-making process regarding the blood chip......................................................................................... 51 Figure 19: Required steps for issuing a RFC .................................................................................................................... 52 Figure 20: Use case diagram ............................................................................................................................................. 54 Figure 21: Activity diagram .............................................................................................................................................. 55 Figure 22: UML example using XML code ..................................................................................................................... 56 Figure 23: Public key infrastructure ................................................................................................................................. 61 Figure 24: Timestamp infrastructure ................................................................................................................................ 62 Figure 25: Secure communication .................................................................................................................................... 63 Figure 26: Needed situation .............................................................................................................................................. 67 Figure 27: Blood chip ....................................................................................................................................................... 81 Figure 28: Blood chip infrastructure ................................................................................................................................. 82 Figure 29: Tunstall interest ............................................................................................................................................... 85 Figure 30: Blood pressure monitor ................................................................................................................................... 86 Figure 31: Automated blood pressure monitor ................................................................................................................. 87 Figure 32: Wight scale ...................................................................................................................................................... 87 Figure 33: Wireless weight scale ...................................................................................................................................... 88 List of Tables Table 1: Sequential order of activities needed to be completed ........................................................................................ 12 Table 2: Project management Gantt chart ......................................................................................................................... 13 Table 3: Risk identification............................................................................................................................................... 16 Table 4: Risk probability .................................................................................................................................................. 17 Table 5: Risk strategy ....................................................................................................................................................... 17 Table 6:GOLD Spirometric Criteria for COPD severity .................................................................................................. 74 4 Reading Instructions To better the understanding of the report and to achieve a red line the reader is presented with a short description of every chapter. The chapters include the following: Chapter 1: Concerning the scientific approach used in the report and clarifying what needed to be answered and which obstacles needed to be overcome. Chapter 2: This chapter offers an understanding of telemedicine and what our TeleMed machine can contribute with. Major parts of our gathered information are shared in this chapter to lay a fundament for the following chapters. Chapter 3: This chapter concerns the practical procedures of running the machine - from the very beginning until ending up on the market. Chapter 4: This chapter makes clear in which ways TeleMed differentiate itself from competitors and analysis’ markets. Chapter 5: Can be seen as an ending making clear that our idea already has gained interest and an opening for what possible investors can be. 5 Chapter 1 1.1 Introduction At the beginning of this semester we were offered the possibility of going in depth with one area out of cognitive radio and telemedicine. After conducting a detailed analysis on the business potential of the two possibilities we have agreed upon choosing telemedicine as we have identified an immediate demand on the market. During this report we are going to briefly present the different questions that we have formulated during this semester, analyse what telemedicine is, and present current trends in telemedicine continuing with a thorough analysis of TeleMed, finishing up with differentiating aspects and interest already shown in TeleMed. The biggest problem that we had to face during our work was related to focusing on only a few aspects of TeleMed. As the reader is going to discover in the next chapters, the TeleMed concept is a really complex project, involving different entities and skills. In order for the idea to become reality it has to be analysed from all possible perspectives (technical, financial, legislative, etc) which we soon discovered that was practically impossible to do in only 3 months. Analyzing every possible aspect in such a short period of time was something beyond our reach and so we decided to make the most of our background knowledge and skills, focusing on infrastructure issues. Even though the term infrastructure can still seem really broad, after going through chapter 3, our approach is going to become clear. The first definition that we came across was the following: ”Telemedicine is the delivery of health-related services and information via telecommunications technologies. Telemedicine delivery could be as simple as two health professionals discussing a case over the telephone, or as sophisticated as using videoconferencing between providers at facilities in two countries, or even as complex as robotic technology” [Telemedint.net.(2009)]. The idea for our project started building on this approach – we now knew what the limits were. The goal that we had in mind was to find a means of improving the general healthcare in Denmark and in the same time providing help for medical professionals in their every day work. Another clarification is necessary at this point: none of us had any knowledge about medical terms or medical tests, as our backgrounds were business, information technology and telecommunications. This was the first connection we made – telemedicine involves different knowledge and different skills that went hand in hand with our different backgrounds. The missing piece of the puzzle was the medical knowledge which we have tried to compensate by discussing with lung specialists and blood specialists (see chapter 2.3 for more information). It is probably safe to assume that “improving general health” is again a very broad term, one that could be questioned as we are not inventing a new medical test or a new medicine. To shed some light on the matter, we will only reveal that telemedicine could focus on curative aspects as well as preventing aspects. With this in mind, it will be easier to understand our point of view and our focus. We are not re-inventing the wheel, but we are putting together technologies and medical tests already available on the market in a new way while adding changes in regards to the infrastructure. Is not that one part of what innovation is all about? 6 Now that our way of thinking is explained, it is easier to introduce the reader to the structure of the report. A good business idea is one that fills a void on the market or one that fulfils a demand-side request, which means that a problem formulation (synonym to a demand on the market) needs to be addressed. Resolving a problem could sometime be done in a chaotic way, but this is not the case for a business proposal. The steps taken need to be thoroughly planned and analyzed by presenting a systematical approach – the methodology chapter. For an efficient way of working a time-schedule should be presented. TeleMed could be facing a number of obstacles (risks) which means that risks factors need to be considered – the project management chapter. As mentioned before, the point was not to reinvent the wheel, so a brief analysis of already existing telemedicine projects in Denmark and in the world was required. In order to determine if there was a market for TeleMed, we performed a questionnaire asking 200 people in Aalborg what they think about the machine, about the tests and most importantly about their trust in technology. For the results of the questionnaire, the reader should refer to sub-chapter 2.4. We were now able to come up with a concept from which to start working on. The continuation supposed working on the infrastructure area, trying to answer the following questions: 1. 2. 3. 4. 5. 6. How to finance TeleMed? Who should be in charge of the eventual changes? What are the costs of TeleMed? Is there a need for a service desk? What does the Danish legislation say about telemedicine? How can security threats be overcome for a TeleMed web-based application? This short introduction has prepared the field for diving into analyzing TeleMed, starting with the problem formulation. 1.2 Problem formulation 1.2.1 Initiating problem In order to find a problem/need that TeleMed can solve/fulfil, the following question needs to be answered: “How can the general health of the population of Denmark be improved by the use of technology?” Figure 1: How to improve the general health in Denmark? 7 This way of formulating the problem is simple - maybe too simple. There are so many possibilities which drive an innovative approach far from being the simplest decision possible. The key in the last phrase is “innovative”. Innovation, in the Schumpeterian sense [Schumpeter, 1939] could refer to new products, new ways of organizing businesses, new processes, or new markets. In the same time, innovation is different from invention in the sense that it can make use of already existent e.g. technologies or products in a new way. This could of course lead into the trap of re-inventing the wheel so we need to consider the aspects that support our problem formulation. 1.2.2 Supporting initiating problems In order to solve the main problem, we need to take in consideration the following guiding questions: - What is the current situation of telemedicine in Denmark? What are the things already done in this direction? How can improvements be brought to the way things are done right now in telemedicine? Is there a need for changing the infrastructure? What is the role that technology plays right now in telemedicine and how can we enhance the technological role? If a new concept is developed, what could the specifications (criteria for the constituent parts) for it be? 1.3 Methodology At this point, the goals for this project are set and a number of supporting questions have been formulated, but the way in which these questions are going to be answered is not clear – we have a problem/demand but how do we solve/fulfil it?. To shed light on the path that will be followed in order for TeleMed to reach its goal, a methodology – a systematic approach - will be needed. Step 1: The problem It is fair to consider that the telemedicine approaches are of two kinds: o A curative one – focusing on dealing with medical problems after they appear. o A preventive one – focusing on preventing medical problems. The problem identified during our research (meaning the questionnaires, interviews, etc) is that most people request medical care after they identify a problem and focus less on preventing medical problems from appearing. One way of preventing medical problems from appearing could be regular medical appointments. Unfortunately, for a number of reasons, the number of persons that have their regular check-ups as often as they should is very small while comparing to the number of persons that handle a 8 medical issue only after appearing. Also, we feel there is a need for a centralized point for medical information on nutrition or symptoms as more and more people check their symptoms on the internet, on a number of websites more or less approved and with more or less accurate information. Step 2: Why is it a problem? The answer to this question is relatively simple – it is easier to prevent something from happening than dealing with it afterwards, not to mention the decreased costs – both for the patients and for the government. Step 3: How do we solve it? Let us now analyze the path followed in order to solve the presented problem. This report is built upon the Problem solving model (see figure 2 below) which suits our problem statement exceptionally well. The starting point could be the theory block which follows after the problem formulation (figure 2). In this block the theory is represented by the existing articles and books over telemedicine. This area is a relatively new one with developments being carried at an amazing pace. Still the number of books on the topic is not very large. One of the most significant guiding books in our development was the “Advanced Health Telematics and Telemedicine” – the Magdeburg Expert Summit Textbook [Pharow & Blobel, 2003b], which presented the situation of different projects and pilot studies in Europe as well as general security, legal, social and ethical aspects of Telemedicine. The problem formulation block is also connected to the empirical data block which again reflects exactly our approach. Since the already existing articles and books were not considered sufficient for developing our business idea, we have opted to supplement the theory with data collected by ourselves. This data came in different forms: o o Interviews with Kim Larving a blood specialist from Bloddonorene at Aalborg Hospital (The Blood Donors), Lene Birket-Smith (a lung specialist) from Aalborg Hospital, Dr. Birthe Dinesen from Aalborg University and discussions with lawyers and distributors. Questionnaires – to develop a viable business idea you have to keep close to the targeted users, identifying their needs and trying to find the best possible solution based on their requests. The questionnaire that we have performed in Aalborg focused on determining what kind of people would be interested in using TeleMed and where they want it to be located. Figure 2: Problem solving model 9 All the information that was collected in these ways needed to be analyzed, interpreted and eventually formulated under the form of conclusions and answers to our initial questions. The final point which is not represented in the diagram above could be best formulated as a test/demo/pilot study. In order for this to be accomplished, we have established contact to a Telemedicine Company, Tunstall Healthcare, trying to evaluate the value of our project. The outcome of the contacts and meetings are presented in the first to final chapter of the report. 1.4 Project management 1.4.1 Why is it important to analyze Project Management? “Projects, rather than repetitive tasks, are now the basis for most value-added in business.”[Peters, 1992].Having a good idea and a good way of solving a problem might sometimes not lead to the expected success unless it is accompanied by an efficient time planning resolution for the project. The task of timeplanning was not a simple one, as previous experience in working with these kinds of projects was limited. Usually, the task of accomplishing a project can be illustrated in the following way, as presented in [Brandon, 2006]: Figure 3: Tasks for accomplishing a project As can immediately be observed, there is a feedback loop – for example initial planning could lead to a certain scheduling but after controlling (monitoring) it could happen that the results are not the expected ones. In this case, planning could be changed, possibly leading to a new scheduling and so on. 10 1.4.2 Why are we together? Putting together a good team is crucial to a project. When putting a team together, it is important to look at what the individuals are good at. Unfortunately, given the small number of people interested in the Innovative Communication Technologies and Entrepreneurship program, the choice was already made. This came as another challenge, as no one was aware of the strengths and weaknesses of the other members of the group. We had to discover this on the way and make the most out of what we had. It was obvious even from the beginning that we have different skills and backgrounds, but what was not just as obvious was the way we can put these differences together and accomplish our goals. The first task in order for this to happen was to determine the weaknesses and strengths of each group member while trying to develop a level of respect and friendship between us. The aspects mentioned above are meant to somehow explain the way tasks have been given out to each participant in the planning process. In this part of the report, we will go through the planning process, how to break down the project and make the process manageable and well-arranged from beginning to end. We will go through potential problems and constraints for the project and how to avoid them. In this course of action, we will touch upon actual deviations that have happened. In the end, we will evaluate the project and compare our plan with what became the reality. Project Definition A project can be defined as a collaborative or individual assignment that is carefully planned and designed to achieve a particular aim. A well-known definition from an expert in project management, Jeffrey Pinto, defines a project as: “A complex one time process developed to resolve a clear goal or set of goals and is limited by budget, schedule and resources” [Pinto & Slevin, 1987]. 1.4.3 Scheduling of Project For an efficient project scheduling, the necessary steps need to be set up. These steps can be narrowed down further into various tasks (activities) that we need to perform in order to complete the project. The sequential order by which these activities can be carried out is termed as project scheduling. This will help us to make the best use of our time and resources. This being said, it is time to outline the various activities that need to be completed in a sequential order, thus identifying which activities are predecessors and successors. The table 1 below shows an outline of the individual activities needed to be carried out in this project. 11 1. Considering project area 2. Problem formulation/statement 3. Methodology 4. Project management 14. Service desk 15. Human infrastructure 16. Fitting legislation in the infrastructure 17. Worldwide technical aspects related to TeleMed 5. Chosen area description 6. Current projects in Denmark 7. Idea screening and evaluation 8. Analyze existing solutions 9. Interview area specialists 10. Description of idea capabilities 11. Presentation of our infrastructural idea 12. Financial infrastructure 13. Change management 18. Security requirements 19. Security of web based applications 20. Security – PKI situation in Denmark 21. Specific tests 22. Future developments 23. Report writing - proof reading & conclusion 24. Final editing 25. Printing 26. Hand in Table 1: Sequential order of activities needed to be completed Choice of network diagram (AON VS. AOA, GANTT CHART) There are two ways of representing the activities: as nodes or as arrows between activity nodes. Let us briefly analyze the differences in approach between these two techniques. In the activities on arrow (AOA) diagram one can show the finish-to-start relationships, the arrow representing that the activity spans the time from the event at the start of the arrow to the event at the end [Brandon, 2006]. In the activity on node (AON) diagrams the activity is placed on the node, while the arrows now show the precedence and relationships between activities [Brandon, 2006]. It is safe to claim that the AON network diagrams emphasize the tasks, which is one of the reasons we have chosen this approach. Also, the AON network diagrams are considerably easier to construct than AOA network diagrams, and are easier to understand than AOA for inexperienced users, this being the situation for our group at the beginning of the project. The fact that the group lacked experience while dealing with these kinds of projects is reflected even more in choosing the AON, as it gives the possibility of ease of revision in case changes appear [Brandon, 2006]. After the short comparison between AOA and AON the choice of the Gantt chart for project management is easier to justify. As you can see from the Gantt chart (figure 4) it is easy to identify which dates the activities are to be completed, how long the activity will take and the precedence between activities. If any activity is completed earlier or delayed, the Gantt chart allows us to update it and provides us with the effect this early completion or delay will have on the entire project. In this context it is also important to define the slack time – the period by which an activity can be delayed without affecting the rest of the project [Brandon, 2006]. Duration of activities We have to make an estimate of the duration that the various activities to be completed will take. The experience of working in such projects was somehow missing, but each member of the group had a level of experience with different tasks (activities). Based on these own experiences we have made qualified estimations. To ensure that our estimations are reasonable, we will consider adding plus/minus deviation 12 of the tasks (see the definition of the slack time). The scheduling of our project has been depicted in the Gantt chart. Note: (+x) needs to be interpreted as a sign of the slack time. E.g. (+1) - represents a slack time of 1 day that does not affect the rest of the activities. Project management Gantt Chart Tasks Considering project area Problem formulation/statement Methodology Project management Chosen area description Start Date 2009.09.02 2009.09.08 2009.09.10 2009.09.13 2009.09.21 Current projects in Denmark Idea screening and evaluation Analyze existing solutions Description of idea (capabilities) Specific tests Financing infrastructure Duration(days) 6 2 2 7(+1) 1 End Date 2009.09.07 2009.09.09 2009.09.12 2009.09.21 2009.09.22 2009.09.21 2009.09.28 2009.10.07 2009.10.09 2009.10.17 2009.10.17 3(+1) 10(+2) 2 5(+2) 10(+2) 9(+2) 2009.09.25 2009.10.07 2009.10.09 2009.10.16 2009.10.29 2009.10.28 Change management Break due to exams Service desk Human infrastructure Fitting legislation in the infrastructure Security requirements 2009.10.17 2009.10.29 2009.11.07 2009.11.07 2009.11.09 2009.11.18 2 8 2 2 7(+2) 3(+1) 2009.10.19 2009.11.06 2009.11.09 2009.11.09 2009.11.18 2009.11.22 Security of web based applications Client server database Security - PKI situation in Denmark Worldwide telemedicine technical aspects related to TeleMed Future developments Distributors & Conclusion Final editing Printing Hand in 2009.11.22 2009.11.25 2009.11.25 3 2 2 2009.11.25 2009.11.27 2009.11.27 2009.11.22 2009.11.22 2009.11.29 2009.12.08 2009.12.15 2009.12.16 4 5(+1) 5 5 1 1 2009.11.26 2009.11.29 2009.12.04 2009.12.14 2009.12.16 2009.12.16 Table 2: Project management Gantt chart 13 2-Sep 9-Sep 16-Sep 23-Sep 30-Sep 7-Oct 14-Oct 21-Oct 28-Oct 4-Nov 11-Nov 18-Nov 25-Nov 2-Dec 9-Dec 16-Dec Tasks Considering project area Problem formulation/statement Methodology Project management Chosen area description Current projects in Denmark Idea screening and evaluation Analyze existing solutions Description of idea (capabilities) 6 2 2 7 1 3 10 2 5 Specific tests 10 Financing infrastructure Change management Break due to exams 9 2 8 Service desk 2 Human infrastructure 2 Fitting legislation in the infrastructure Security requirements Security of web based applications 7 3 3 Client server database 2 Security - PKI situation in Denmark 2 Telemedicine tech. aspects related to TeleMed 4 Future developments 5 Distributors & Conclusion Final editing 5 5 Printing 1 Hand in Figure 4: Gantt chart 1 14 1.4.4 Identifying Stakeholders Now that we have scheduled our tasks and estimated the duration, we have to identify the stakeholders. These are all of the interest groups that play a part in the project either directly or indirectly. In relation to our project, we can establish the stakeholders as follows: Aalborg University •Responsible for our examination and setting the requirements for the project. This is the administrative part of the project. ICTE7 group •This includes the members of the team: Andrei, Claus and Juras Figure 5: Stakeholders of the project 1.5 Risk Management Before analyzing different aspects of the risk management, a clarification over the term risk is required: a risk has a chance/probability above 0% and below 100% of happening and could have a positive or negative impact [Brandon, 2006]. Risk Management Plan In managing risks, a number of stages can be determined, as presented in [Brandon, 2006]. We are going to focus only on the following four stages: ï‚· ï‚· ï‚· ï‚· Risk Identification Risk Quantification (probability and consequences) Risk Response Risk Monitoring and Control 15 1.5.1 Risk Identification The first point of action is identifying the risks. Risks could fall under one of the two categories: ï‚· ï‚· A generic risks category - characteristic to a number of projects (e.g. users might not be available). A standard mitigation solution can be used with this category. A TeleMed-specific risks category. Under this category we can identify the following risks: a. b. c. d. e. f. g. h. i. One or more devices implied in one of the tests have malfunctions while users are performing tests Complete system failures Soft certificate (digital signatures) might not be sufficient from a security point of view A change in the current legislation Similar or even more technologically appealing machines are created by other companies Unwillingness of doctors to accept TeleMed Unwillingness of users to rely on the results produced by TeleMed Impossibility of transferring the information to the user’s Electronic Health Record Development of additional equipments for usual tests At this stage it is not enough to identify risks; their impact needs to be asserted according to [Brandon, 2006] (note – in the following table a. represents the risk a. identified above in the a. – i. list of risks). Cause a. Misuse or technical problem b. Misuse or technical problem c. Attackers trying to exploit the system d. New laws passed by the government e. Telemedicine projects receive extra-funding from the government f. TeleMed is perceived as an extra-load g. TeleMed is not offered enough time to build a reputation h. Software/hardware failures i. Increased interest in telemedicine Impact a. Decrease of reputation and trust in TeleMed b. Complete lost of reputation c. Decrease of reputation and trust in TeleMed d. Deployment could be delayed e. Deployment could be delayed or canceled / Project canceled f. Deployment could be delayed / Project canceled g. The project could be canceled h. Reputation is lost i. RFC’s need to be formulated Table 3: Risk identification 1.5.2 Risk Quantification (probability and consequences) The second step aims at answering the question relating to the probability of the risk: How likely is it that the identified risk is going to occur? In order to offer an accurate answer to this question risks need to be quantified in two dimensions while evaluating the impact of the risk and the probability [Brandon, 2006]. For evaluating these two parameters two methods are available: ï‚· Qualitative – past data, educated guess ï‚· Quantitative – based on formulas or statistical data For TeleMed we chose to express the parameters on a 1(low) to 3(high) scale (even though it is less precise, it seems a more viable option for projects as complex as TeleMed). By using a matrix as indicated below, a priority (impact potential) can be established. If the risk has a high probability and a low impact then we are 16 dealing with a medium risk, but on the other hand, if the risk has a high impact and a low probability then it is crucial to deal immediately with that risk. Probability Low Medium High Impact Medium Low C A, H B, D High F, G E I Table 4: Risk probability 1.5.3 Risk Response Also called risk mitigation strategy, this paragraph focuses on answering the following question: What is the way that risks can be dealt with? There are four possibilities as described by Brandon [Brandon. 2006]: ï‚· ï‚· ï‚· ï‚· Avoidance. Eliminate the cause Transfer the risk. Move the responsibility to a second party (e.g. a vendor). Mitigate the risk. The impact or the chance of the risk occurring needs to be reduced. Acceptance. Take no preventive action as the risk is not worth it. A risk response plan should include the strategy and action items to address the strategy. Risk a Strategy Avoidance – During the pilot study all possibilities of usage of TeleMed should be tested b Mitigation – Prepare a backup equipment that could immediately replace the malfunctioning equipment Avoidance – Test different scenarios during the pilot study c d e Mitigation – Enforce maintenance contracts Avoidance – The introduction of smart cards should be debated Acceptance – In this situation the risk is out of the reach of the TeleMed innovaters Avoidance – Gain governmental support Mitigation – Investigate new developments through RFC’s f g h. Acceptance – Developing a solution that comprises the newest technologies Avoidance – Gain governmental support Mitigation + Acceptance– Governmental campaigns for educating the users Avoidance – Perform thorough tests during pilot studies i. Mitigation – Enforce software maintenance contracts Acceptance – Put in place a Change Advisory Board (CAB) Table 5: Risk strategy 17 1.5.4 Risk Control The process of risk management should be a continual one – risks should be monitored permanently, as they have the chance of turning into an issue. The next step after removing present risks is identifying new risks, going through the entire process of risk management again. Figure 6: Risk control 18 Chapter 2 2.1 Introduction to telemedicine By definition, telemedicine implies receiving professional medical health-care, remotely, through the help of innovative information and communications technologies Telemedint.net.(2009)]. If we try to go in depth with the definition, we will find out that in order to receive this kind of care one has to rely on technologies like mobile phones applications or Internet to transfer the information towards the designated doctor, eliminating limitations related to distance. Immediately after analyzing this definition, the problem of security as well as the problem of legal and ethical issues comes into mind. For now we are going to focus on presenting a short insight on what telemedicine means and current developments as the other issues are all to be discussed in the following chapters. One of the greatest problems that telemedicine tackles is providing help to rural or damaged by catastrophic events areas, where sometimes doctors are not able to reach or the existing staff is neither prepared nor trained in dealing with complex problems. Nevertheless, telemedicine should be regarded as a possibility for countries of all kinds. People in the countries referred to as more developed countries as well as people in less developed countries should be able to take advantage of the benefits brought by telemedicine, thus providing an increase in the overall health system. Our main focus throughout this paper is a telemedicine service in Denmark and we are going to prove that telemedicine can serve even in a country that, so far, does not rely on so many projects on-going in this area. Also, the applications of telemedicine expand way beyond the simple image created in rural and catastrophic events damaged areas. To have the exact picture of why telemedicine is becoming one of the most interesting fields in which research is being conducted, one meaningful example could be set. The three hour window following a stroke is crucial for the patient. The stroke is of two types – ischemic or hemorrhagic [Hinkle, McKenna, 2007]. In the first case, administering thrombolytic drugs can diminish the probability of serious long term damage. On the other hand, administering these drugs to a patient that had a hemorrhagic stroke could turn to be a life-losing situation. This situation could be alleviated by use of communication technologies like video-conferencing, for example [Pedersen, 2009]. The first definition that we have presented included the term remotely which is not, by far, a new concept. Before the development of innovative communications technologies, the possibility of receiving medical care from a distance imposed the usage of the usual mails. None the less, the 20th century was marked by an incredible advance in technology which created the starting grounds for deploying new methods aimed to help people by receiving improved medical care. Telemedicine has evolved so much in the last years that now we are able to properly determine three categories of telemedicine [Borkowski & Mielniczuk, 2003]: ï‚· Store and forward – the patient takes the required tests and the results are sent to a doctor for evaluation, thus eliminating the need for physical consult. The category under discussion does not 19 involve time-critical or life-critical tests. This is in no way a method targeting to replace the usual check-ups that people need to take periodically, but a chance for people to enhance the possibilities for these tests (especially people who have some concerns about going to a doctor’s office on a regular basis or people who do not find the time for this). ï‚· Self-monitoring – compared to the first category, this one involves the existence of a specific disease that doctors can monitor remotely. The benefits of this category are the possibility of rapid action taking and cost-efficient monitoring. Cost-effectiveness comes from the fact that patients that use self-monitoring services are not required to go to the doctor as often as they were supposed to, permitting the doctor to take care of more cases. ï‚· Clinician interactive – it usually involves real-time consultation of a person through the use of video-conference or phone-conversations. This category is especially useful for regions in which doctors cannot provide regular help. For example, in some countries in Africa, a doctor that is located in a city, could have the responsibility of up to 70,000 people, most of which live in the rural areas, making transport and access particularly hard [BMJ, 2000]. This category is probably the most well known category, as the correlated applications have experienced world recognition. Doctors and medical staff in different countries can take advantage of the different expertise around the globe in situations that could be proving life-saving. There have been (and are still being developed) different projects aiming at interconnecting hospitals from different countries or maybe even continents in a virtual way, thus helping patients, increasing the expertise level in these countries and greatly decreasing overall costs. While categorizing the types of telemedicine, we have used the term “service”, referring to some applications in this field. These services (having a primary focus on self-monitoring services) are intended to be marketed in countries referred to as most developed, on a financial and technological level. Also, another important aspect that should be held in mind is the fact that the perspectives offered by telemedicine are not only in the treatment area, but also in the diagnosis area. The most obvious example is related to countries that have a high number of persons that have to deal with the HIV disease [Lemens, 2009]. The treatment of this disease is an extremely challenging situation that leads to high costs. Recent research has shown that a small sensor installed on a regular mobile phone that receives a blood test sample can prove to be an extremely useful tool in diagnosing and preventing the HIV disease [Lemens, 2009]. Another important aspect that catches the eye is related again to the first definition – telemedicine makes use of innovative communications technologies. Why does that definition make use of the word ”innovative” if technologies that are currently being used in this field have been around for years? The innovative part does not mean that the Internet, the mobile phones or other technologies deployed are new inventions that drive telemedicine forward, but simply a new way to combine all the existing technologies. We are not denying in any way that telemedicine could involve the deployment of inventions, but the term innovative seems the most appropriate to use, even in correlation to the following chapters, that presents the TeleMed machine. 20 2.1.1 What drives telemedicine forward? A possible answer could be that the current progress that telemedicine is experiencing can be correlated with the increasing interest (and of course investments in research) of major equipment providers (such as Cisco, Ericsson, etc). Recent work taking place in the research facilities e.g. of Cisco or in the Scandinavian region has one more central point – telemedicine. For more references, readers are more than welcome to document themselves on the latest Health Presence Pilot project from Cisco [Cisco’s Health Presence (2009)]] or on the Gramjyoti Project [Gramjyoti(2009)]. The interest of companies like these is viewed as a turning point, one that could add to the reliability and security of this field, especially if we consider the clinician-interactive category of telemedicine. 2.1.2 Current projects in Denmark Situation in Denmark – until 2001, no significant work of embracing telemedicine was noted. A working group called the Danish Board of Technology determined through the use of different studies that telemedicine could be used to decrease costs for the government and enhance the quality of health care [Danish Board of Technology, 2001]. In one of the reports presented by this work group [Danish Board of Technology, 2001], the problem of lacking local health staff is debated, presenting the way how telemedicine will influence this matter. There is also a discussion over the improvement in quality of diagnostics and treatment by centralizing the knowledge and expertise in a few centers. Overall, this has constituted the start of reorganizing the health sector and services offered in Denmark. The importance of telemedicine was illustrated through the example of strokes. Determining the type of stroke is conducted with the use of a magnetic resonance imaging (MRI) machine, which involves a radiologist with particular background and knowledge. Unfortunately, these radiologists are very scarcely distributed, fact that proves out to be a particularly big problem in Denmark. The expertise of this type is provided in centers like Odense University Hospital [Pedersen, 2009], which is hardly sufficient to meet all the needs of Danish citizens. Time is of the essence in telemedicine, and the three hour window comes to prove this. Having so few centers specialized in dealing with this particular medical condition could turn out to be a really fierce problem in the case that patients cannot make it to the hospital in due time. Fortunately, telemedicine comes to meet this problem making use of videoconferencing. Another ongoing project in Denmark that is meant to solve the problem of insufficient medical staff trained in particular medical area brings benefits to both Denmark and the Baltic states, like Lithuania and Latvia. The project is called the Baltic e-Health and actually solves two stringent problems in the same time. First one is the lack of radiologists in certain regions of Denmark, the second being the unemployment of these specialists in Latvia and Lithuania, due to the insufficient work places for these professionals [Sørensen & Svendsen, 2007]. There are also other advantages in this approach, the main ones being the timeeffectiveness (we have already stated that time is of the essence in telemedicine) and cost-effectiveness. The latter refers to the fact that there is no need to relocate the specialists from their countries, giving them the chance to also help in their countries, if possible. 21 The last project relevant in the Telemedicine area that we have come across is the Telekat project, mentioned several times in the report. A leaflet from Telekat is attached to this report. 2.1.3 Idea screening/idea evaluation The reader could ask himself/herself at this point how this is relevant in any way to the TeleMed project. By underlining the current focus in telemedicine (the curative approach) we are actually emphasizing the need for a preventive approach. The traditional preventive way until now was a usual visit to the doctor every 6 months (in theory), where different tests could be run in order to check one’s health condition. How many people actually follow this approach? This is not something that could be concluded from any previous studies, thus we have identified the need for gathering empirical data, under the form of questionnaires and interviews. 2.2. Model of what TeleMed can do After analyzing the current projects related to telemedicine that were or still are in progress in Denmark, it is easier to identify the void that TeleMed can fill on the market. TeleMed should not be aimed at enhancing the treatment methods (the curative approach) but is aimed at tackling the preventive approach. After a period of brainstorming and intense analysis of the equipments existing on the market, we were able to come up with a list of capabilities and tests that TeleMed should incorporate – First of all TeleMed should incorporate general information about different symptoms and information regarding nutrition and fitness programmes. The reason behind this choice was the increased usage of the Internet (and sometimes unreliable sources) for finding out more information especially about symptoms. Currently, in Denmark there is a solution in this sense, represented by sundhed.dk [Rasmussen, 2009]. Providing more sources with authorized health information could increase the basic knowledge of the common patient. Naming one example – while coming home, you are experiencing different symptoms and you want to find out what could be the cause, without waiting until you get home where you allegedly have internet access. If you are part of the category that does not want to contact the doctor first, TeleMed could be the first source of information. We understand that speed in providing information in this case is essential for the situation described above so no login will be required for the user, offering the possibility of determining a possible cause in just a few minutes. Moving on to more complex features of TeleMed, in the problem formulation we have identified a problem in the category of people that do not perform regular check-ups as often as required by medical staff. But what are the tests usually performed in a regular check-up? The most important test is related to blood samples from which a list of parameters is calculated – glucose level and oxygen saturation, etc. Usual blood test is performed by extracting blood directly from the veins, using a needle, but is in the TeleMed machine done by finger prick tests. The list of tests also includes checking the health of the lungs (Pulmonary function studies – e.g. forced vital capacity (Spirometry)), height and weight measurements (useful in determining parameters like Body Mass Index), and sometime eye tests. Finally blood pressure and pulse can also be measured by pulsoxymetry. As a more futuristic approach we decided on 22 implementing RFID-patches since these already are valid to use. All the methods for performing the measurements are explained later in the report. In determining how these tests can be included in TeleMed we have also set as a goal offering benefits in contrast to usual check-ups. Including tests like these in a machine gives rise to a number of questions: ï‚· ï‚· ï‚· ï‚· ï‚· Can a patient take blood samples on his own if TeleMed is going to be placed in a location where medical staff is not present? If the location permits the presence of a medical staff (or specially trained staff) is there a viable possibility of storing blood samples? Could the mitigation of hygiene issues addressed above take place by incorporating the finger-prick test instead of usual blood samples? Is this a scientifically accepted option? If one-time results of tests performed within TeleMed are not concluding how can we offer the possibility of gathering statistics, increasing reliability? In regards to pulmonary tests, could the results be presented in just a few minutes? (this would be a differentiating aspects in regards to usual check-ups) Are these results reliable and can hygiene be assured even if medical staff would not be present? To illustrate what exactly the TeleMed machine has to offer the user, see the model below: Figure 7: TeleMed machine capabilities 23 2.2.1 Features of TeleMed After outlining what the TeleMed machine can do, it is now possible to be more explicit on the workings of the machine. Most features of the TeleMed machine are mentioned later in chapter 4 since they are differentiated offers not seen in other health kiosks on the market. The features described in this chapter are implemented in other health kiosks such as StayHealthy (See chapter 4) but are still highly relevant to offer the users. One idea that exists in some health kiosks which we decided on not implementing is ear test. To perform an acceptable ear test many specialist believe an otoscopy examination is needed [Heneghan et. al., 1999]. An otoscopy test is most often picture or video coverage of the ear canal or ear drums, which makes a more precise result than offered by simple headphone tests (Sounds playing in different volumes followed up by questions to the listener to determine the quality of hearing) performed at other health kiosks. Using the otoscopy test in a self-serviced machine seems unreasonable since the test is difficult to perform, and no immediate answers can be supplied to the user, since the picture/movie needs to be examined by a specialist – and only offering a headphone test to the user has been judge invalid since results are related to many factors such as age, colds and the lately pressure on the ears. 2.2.2 Blood pressure test One of the dangerous factors that can easily be measured in the body is the blood pressure. Blood pressure can cause a threatening number of diseases/attacks, such as heart attacks, diabetes, kidney diseases [Opelz et. al., 1998] and in general a weak immune system [Hansson et. al., 1998]. Measuring blood pressure in the TeleMed machine might turn out as the most preventive tool offered, and it is ironically also the easiest one to implement. Normally, a doctor would put a special bandage around the patients arm and have immediate results, but in the TeleMed machine the user place the hand wrist in a tube which automatically fits the wrist, and within seconds presents results. This method is already used in various hospitals being a time safer for the nurses [A&D]. It is easy to perform the test and there are no risks involved, and the results are fairly accurate – the only things that can blurry the results are high/low body temperature or recent exercise (this will be informed to the user before carrying out the test). At the moment, many patients use telemedicine to monitor their blood pressure from home (e.g. the TELEKAT project mentioned later in the report), but it could be argued that having people tested at the TeleMed machine will save the government money, by discovering a potential group in the public with high or low blood pressure who were not aware of the dangerous situation they were in. Not only there are many people in the danger zone regarding high or low blood pressure, but the people being attacked by the consequences, can be attacked without any warning signs – The blood pressure is the result of the blood being pumped from the heart to create oxygen in the veins, without this oxygen (or blood stream to move blockages) immediate attacks can occur without warnings [Americanheart]. This means that people who were considered healthy might all the sudden be seriously sick needing regular medical assistance. It would be of great importance to have the general public tested frequently in the TeleMed machine to avoid these insidiously setbacks, which a potentially big group is in the danger zone of. 24 After the user has received the results of the test, the user will either be proved fit or unstable. If unstable, the user will be introduced to the many various reasons that may have caused the high or low blood pressure, such as obesity, stress, kidney diseases etc to offer immediate guidance. If the result is alarming, the user will be suggested to schedule a doctor appointment. Also, it could be suggested that the government should run campaigns encouraging people in the risk of blood pressure problems to get tested - the risk increases with before mentioned situations, but also with more natural factors like age, gender and pregnancy [Wiinberg et. al., 1995]. 2.2.3 Pulsoxymeter A pulsoxymeter device offers an easy way of checking pulse and high/low saturation. The only thing needed to perform the test is the fingertip of the user (without any penetration of the skin). A finger clip gathers around the finger tip and results are presented after a few seconds. Pulsoxymeter test devices have been for sale for reasonable prices on the ordinary market for many years, and are already implemented in e.g. TELEKAT. Pulse measurements are important to avoid risks of fungi, heart diseases [Franklin et. al., 1999] and vascular diseases (affecting the circulation system) [Cohn et. al., 1995] among other diseases. Saturation tests are important to make sure the blood carries sufficient oxygen in the red blood cells [Harvard Health Publication, 2009]. The diseases related to problems with saturation are quite similar to the ones mentioned regarding pulse. There should be no complications of implementing a pulsoxymeter in the TeleMed machine since costs are low and the usage is easy. The results have been accepted for years and there are no dangers related. 2.2.4 Eye vision test An innovative idea to be integrated in the TeleMed machine is eye test. The main idea is not new and was developed by SoloHealth as a product called Eyesite, but their proposal is a totally separate kiosk which can assess initial eye sight test, make appointment with a specialist and read about eye diseases. EyeSite is an award winning self-service vision test kiosk focused on total eye health. Users can get an accurate screening of their vision in about 3 minutes; learn about eye conditions like cataracts, glaucoma (fluid pressure inside the eyes rises because of slowed fluid drainage from the eye [MedicineNet(2003)]), and macular degeneration (damage or breakdown of the macular of the eye. Macula is a small area at the back of the eye that allows us to see fine details clearly: [Macular Degeneration (2009]). And a doctor location feature encourages users to schedule an appointment with an eye care professional to get a full eye health examination [Eyesite, 2009]. SoloHealth has placed the EyeSite kiosks throughout its home base of Atlanta (USA) in retail locations such as Walgreens, Kroger, Walmart and regional malls. Since September 2008, SoloHealth has screened over 100,000 people [Gokis, 2009]. As it seems to be accepted by people, we are offering a new approach to this system by integrating it to our TeleMed machine. How does the user perform the eye test? First of all it is necessary to choose the eye test function in the tests menu. Now the user can choose to see what kind of eye diseases exists or just perform the test. The 25 eye tests could be performed as SoloHealth suggested by answering some general questions in the beginning (like gender, age, previous eye tests, use of contact lenses etc) and then the user are tested with each eye for a near vision, which is done by displaying different sizes of text on the monitor. After each text display, to determine the sight level, questions on how good or bad the user can see displayed text comes up on the monitor. Afterwards the distance vision test takes place; here letters are displayed on a separate smaller monitor placed at the eye level to imitate distance. It is more or less similar to a regular eye checkup which determines your eyes status. When the test is done results with brief explanation are displayed on the monitor and are saved to the user’s medical record. In the case of unclear results the system offers to schedule an appointment with suggested eye care professionals for a full examination. After an appointment is made, results are automatically sent to the selected specialist. Virtual eye tests do not replace eye test examinations by professionals; these are just initial eye tests which encourage the user to take a full eye examination by an eye care professional. The main benefits of this kind of tests are that people will be more aware of their eye’s condition, and e.g. prevent the spread of infection which could lead to blindness. 2.3 Interviews 2.3.1 Interview A – Lung specialist We wanted to ask Lene Birket-Smith based on her expertise if our idea of implementing a tube for measuring the quality of clients’ lungs was a possibility and if other lung-related attributes could be implemented. Also we were informed that Lene Birket-Smith was working on other telemedicine projects that we wanted to know more about. She was for our idea of implementing a tube and could not mention any contradiction towards not using the procedure. We mentioned possible negative criteria, like hygiene and uncertified results but both were not problems according to her. Hygiene was can be easily solved by changing the mouth-part of the tube which is basically just a small plastic tube and uncertain results does not occur since the lung test is straight forward. According to Lene Birket-Smith the lung test shows if persons using the machine have vague lungs and if e.g. cigarettes are too harsh on the lungs – thereby preventing black smoker lungs and cancer. Lene is working as a researcher within lungs and attached to the telemedicine-area. She explained to us that so far telemedicine in Denmark is way behind other countries (especially United Kingdom) and therefore Aalborg Hospital was quite unknown within the telemedicine-area and only brief tasks had been performed so far. She explained it to be lack of knowledge in the field but made clear that it is not lack of funds being the issue since the interest definitely is present. The only major project running at Aalborg Hospital (which she is part of) is called TELEKAT. Lene put us in contact with Dr. Birthe Dinesen at Aalborg University who is working partly on telemedicine who we later on contacted to gain general knowledge. Lene’s comment about Birthe Dinesen was: 26 “Birthe is likely to be the most knowledgeable person about telemedicine in Denmark and is passionate about developing the health sector with telemedicine techniques”. The meeting was positive as she seemed very interested and had no arguments of not implementing lung measurements in our machine. Lene has expressed her desire to see further information later on about our project to gain knowledge about the possibilities for her own research. 2.3.2 Interview B – Blood specialist A lot of questions needed to be clarified within the sphere of blood. Naturally, contact was made to Aalborg Hospital which delightfully made one of their most knowledgeable resources available, Kim Varming. Kim Varming is a medical director at Department of Clinical Immunology and director of Aalborg Hospital’s blood bank. Kim Varming is an experienced and acknowledged doctor with expertise within blood transfusions. At the beginning of the meeting Kim Varming was introduced to our idea in general and to a list of blood measurements. We wanted to know if a blood sample could clarify thoroughly these tests. Also we wanted his point of view on either using ordinary blood samples or finger needle tests in our machine. And lastly we wanted to know if he agreed on the legislation we had been informed earlier on by our two law educated sources (Anna Murphy and Mikkel Dybtved Andersen). It soon became clear that the blood specialist was skeptical about our idea regarding blood samples included in the machine. Neither blood samples nor finger needle tests would be appropriate regarding Kim Varming while more than one test is often needed to clarify a final result of only one parameter – like e.g. cholesterol. A few tests could be performed but would contribute to results that can only be used as signs of problems, but not finally conclude that something is necessarily wrong. One of many examples given by Kim Varming was: “It is common for a doctor to have patients worried about having HIV and the first test performed might be positive, but the following two deny the first by being negative”. Another problem arising, according to Kim Varming, was that maybe only 1 out of 10.000 people have a problem regarding e.g. hemoglobin, so why should perhaps 500 people then be tested? We questioned this statement by the interest of a more healthy country and were informed that each blood sample performed by an ordinary doctor has a cost range between 40 – 300 Danish kroner. As a group we still find this a question of interest but Kim Varming disagreed. Regarding the legislation part Kim Varming agreed with our law sources, he did not see the need of performing blood samples outside of a doctor’s office. He was a fan of the idea of performing other tests such as lungs, heart-rate etc but believed that blood measurements are only suitable for a doctor’s visit. 27 Lastly we asked Kim Varming if he saw any future possibility making our machine work regarding blood measurements. His short answer was no (though scientific papers shows otherwise (see sub-chapter 4.6.2). In the same time, Kim Varming referred to future medical developments such a scanning the iris (eyeball) which can show signs of sickness but is not accepted as a medical method by now. Overall, Kim Varming was against our idea of performing blood samples or finger needle tests and did not see future aspects as a solution. As a group, based on what we have learned from our research, we decided that the future looks brighter concerning easy performable blood sample tests than what Kim Varming states. This stand point will be proven later in this report, especially in the Blood chip section 4.6.2. 2.3.3. Interview C – Telemedicine scientist Grounded information on telemedicine and information about ongoing projects was given by assistant professor Birthe Dinesen from Department of Health Science and Technology at Aalborg University. Throughout the project contact was being kept with Birthe in order for her to give feedback on the TeleMed project and as a whole she had no objections against the idea. Birthe Dinesen, alongside with engineer Bernhard Ege, is in charge of another Danish telemedicine project called TELEKAT (mentioned several times in this report). A leaflet on the TELEKAT project can be found attached in the appendix. The TELEKAT project is cooperating with Tunstall Healthcare which we contacted regarding telemedicine equipment. The only obstacle with the TeleMed project that Birthe Dinesen and Bernhard Ege could find was the usage of digital signature (Bernhard Ege claimed that the process of digital signatures will be going under modifications in the following years, without offering further information). Besides from that, Birthe Dinesen found the TeleMed project interesting and is interested in the final outcome. She made it clear that it is rather easy to achieve economical support for telemedicine-projects in Denmark. She predicted our project to be a major step within Danish infrastructure in the sense that currently integrated telemedicine is on a more basic level, referring only to features installed in private homes. Putting a variety of telemedicine products into one machine and making it available for the wide public would show a major improvement in Danish telemedicine in her opinion. 2.3.4. E-mail conversations A large variety of professionals were contacted in the working process of the report. All of these are mentioned in the report when appropriate, but here is a list of the most relevant sources made use of to make sure our project is possible to launch: - Business Developer at A&D Frank Downing – to gain information about distribution options of telemedicine equipment, to get technical knowledge on A&D’s equipment and to get a list of prices. 28 - Information Chief John Collins at StayHealthy – to get knowledge about the technicalities of StayHealthy and knowledge about possible tests. - Lawyer Mikkel Dybtved Andersen working with legislation at Bloddonerne in Frederiksberg – to make sure our idea of the legislation of collecting blood samples was correct. - Lawyer Anna Murphy head of department at Sundhedsstyrelsen – to make sure our idea of the legislation of telemedical usage was correct. - Managing Director Bjarne Flou from Tunstall Healthcare A/S – to obtain information about telemedicine equipment and because Tunstall Healthcare A/S showed interest in our product. - Head of Section at Faculty of Engineering, Science and Medicine Kenneth Stenkjær Pedersen – to compete in Venture Cup 2009 (entrepreneurial academic competition) and to receive feedback on our ideas. - Associate Professor Anders Henten – to gain knowledge about transaction costs. 2.4 Results of questionnaire overview The questionnaire was build upon Steinar Kvale’s ‘Interview – En introduction til det kvalitative forskningsinterview’. 200 people were interviewed (111 female and 89 male) and counted enough to illustrate a clear picture of the population’s point of view. The interviews were carried out in various places of Aalborg city that we considered as being places with diverse segments of people – such as a main library, train station, market squares and malls. It was important for us not to put words in the mouth of the people being interviewed and to seem neutral about our ideas presented. We have interviewed people from a variety of age categories and as a result the average age of the participants was 35.76 years old. The age differences are categorized to give a clearer picture of the interviewees: Age categories 70 60 50 40 30 20 10 0 15 - 25 26 - 36 37 - 47 48 - 58 59 - 69 70 + Figure 8: Age categories 29 One of the first things to mention is the reticence of most people in talking about the specific chronic disease that some were experiencing. After questioning 50 persons only 4 admitted facing chronic diseases and only one mentioned the nature of the disease – a pulmonary disease. It was becoming obvious that people are feeling somehow embarrassed about speaking about their diseases and this did not come as a surprise. To avoid unpleasant situations, after interviewing 50 persons, the decision of eliminating this question was taken. The point of this question was to determine if people that are already facing different medical conditions are interested in using the TeleMed. Because of this reason we are going to analyze the responses of the specific person separately. The respective person was a 25 years old female which claimed to have a pulmonary problem due to smoking (as to her own words). This person seemed enthusiastic about the perspective of using the TeleMed, especially if the location of the machine would be in a hospital. Regarding how often this person would use the machine, the answer was “every six months”, while the answer for the question “how often do you do your usual check-up?” was less than once per year. These two answers correlated could present a somehow intriguing situation. While asked to list the tests that might be useful for her use, all the available tests were selected, emphasizing the lung tests. 2.4.1 Locations: Reasons and obstacles The first aim of the questionnaire was to determine which location for the TeleMed would be preferred by the interviewed people. We had four locations in mind and these are going to be explained in the following paragraph. The list of locations was created having in mind attractiveness and comfort ability for people who should not feel e.g. embarrassment while using TeleMed. It was assumed that places referred to as being more populated (crowded could be used just as well) would represent a more suitable option as they would give people the possibility of additional services alongside the usual needs that they fulfill in the analyzed location. Here, there is a need of differentiating between people that planned to use TeleMed and people that could use TeleMed only because they were in that location. It is imperative to consider that the list of locations should not include places where people usually find themselves in a hurry. There was another category of locations eliminated from the lists and that was the category of locations where people do not want to spend a lot more time than needed or places where mood is questionable. The examples for this last category could be a Court house, or a police station, while an exception is represented by a hospital (maybe even schools). Moving to the list of locations that people were to be interviewed about, that list included several places considered as best options for TeleMed. At this point it is important to bring into discussion the fact that people had the freedom of expressing new locations that were not included in our lists, locations that were more suitable regarding their needs. The following paragraphs are analyzing the initial list: 30 1. 2. 3. 4. 5. Fitness center Doctor’s office Entrance of a hospital Pharmacy – this one appeared as a possibility after suggestions Shopping center – this one appeared as a possibility after suggestions 1. Fitness center The first location that seemed to check all the above mentioned requirements, in our opinion, was a fitness center. First of all, a fitness center and the TeleMed would have in common the prevention characteristic. This location was classified as a good idea for carrying out simple or ordinary health tests while the emphasis would be on the nutrition and symptoms information. It is claimed that in this kind of location the TeleMed services could complement the services for which people came there in the first place (let us assume that people take the tests provided by TeleMed and are unhappy with the results presented e.g. pulse rate. One immediate option that they have at their disposal is to start exercising programs, for example, exercises offered by the fitness center). This means that in a location of this sort, TeleMed could target people that planned to use it, as well as people that found it by accident (assuming the early days of deployment, where reputation is an issue).The other requirement checked by this kind of location would be “providing an alternative for people who are afraid of hospitals for different reasons (e.g. the environment or lack of time)”, as stated in the previous chapter. The downside of a fitness center would be lack of medical assistance while performing the tests and the category of age for the people that usually attend a fitness center – this would lead us to consider only a younger category of people. Also, not being able to receive medical help from a qualified e.g. nurse/medical assistant has the possibility of creating legal issues. On the other hand, the nutrition information (and exercising programs) presented on TeleMed might be very useful for people who attend fitness center, as TeleMed could complement their training program according to their needs. What are the obstacles that could be encountered in a fitness center? The first obstacle could be related to the willingness of the fitness center of accepting TeleMed. Second obstacle is related to one of the disadvantages – because medical staff cannot be present in the fitness center, the management should make sure that the staff members are properly trained in using all the facilities of the machine (aimed at alleviating some of the hygiene issues and giving assistance to persons when needed). One of the requirements for TeleMed is that it should not pose an embarrassment on people. This requirement could find its solution in using a separate room for TeleMed (compared to the alternative of having it in the lobby, it is assumed that people would choose the alternative with more privacy), which could in turn lead us to reticence from the fitness center management, as they would have to free up important space. When considering the fitness center, it is believed that all reticence should be eliminated while analyzing the advantages. Probably the main advantage for the fitness center would be increased reputation (which later on could be translated by increased number of users), obtained by additional advertising. TeleMed could be advertised by commercials (in television, radio or other media) which would also give the possibility to the fitness center to be also known as “the fitness center that holds the TeleMed”. If the 31 fitness center proves to be the option chosen among the persons interviewed, then the possibility of setting up means by which only one fitness center could host the TeleMed should be found (this would increase the desire of the fitness centers to own it). 2. Doctor’s office The second option on our list was a doctor’s office. When reading about this option, the first question that comes into mind is “wasn’t TeleMed supposed to help people that are afraid of going to a doctor and that prefer going there only when really necessary?” The answer is yes, but in the same time this location does not put under discussion the above requirement. Being afraid of seeing a doctor might have nothing to do with going to his office, if that does not necessarily involve interacting. On the other hand, for people that do not feel comfortable in going to see a doctor, this location could seem ideal, as in the case of unsatisfactory results, a doctor appointment can be immediately made. In the same time, the hygiene issue could be easily alleviated as medical staff could be around the TeleMed all the time, helping people with tests or offering indications. But what would the benefits for the doctors be in this case? As a primary observation, this approach could lead to saving time and becoming more efficient. The usual check-ups could be compensated by the TeleMed tests, while the doctor would be dealing with the more serious cases, focusing on treatment rather than prevention. Another possibility might be formulated in the following way: while waiting to enter into the doctor’s office you could take some tests available. The question here is if this kind of approach would be a redundant one or a more efficient one, as the doctor would already have some indicators when beginning the tests. 3. Entrance to hospital The third location is somehow similar to the second one. The same question of fulfilling the initial requirements is also in place, while the benefit of having medical staff like nurses or medical assistants around to help persons with tests and eliminate the hygiene issue is also present. One of the main differentiation points would be that in the second case it could happen that only a small number of doctors adopt the TeleMed in their offices. A normal question regarding this approach would be if it is a viable option, thinking that only people with serious problems would go to the hospital. A possible answer for this could be related to the time saving feature. Performing tests with TeleMed is aimed at returning the results in just a few minutes, feature that could be also used by the medical staff when dealing with complex cases. But would people be interested in using TeleMed if they did not have to be in the hospital? Is it safe to assume that e.g. while returning home from work, a person would stop at this location just because he/she knows about the TeleMed? This is one question whose answer should be revealed by the questionnaire. 4. Pharmacy This location is one of the places indicated by one of the interviewed persons. Even though it was suggested only by one person, we feel that an analysis should be performed. After analyzing the EHR National Report for Denmark [Rasmussen, 2009], we have discovered that all pharmacies in Denmark make use of IT (100%). IT is used here as a mean of communicating with the general practitioners and hospitals. 32 Thus it could be argued that by placing TeleMed in one of these locations, the possibility of setting up an immediate appointment with the doctor would be made easier by the existing IT infrastructure. Another advantage would be the help that could be received while performing the tests from the persons working in the pharmacy (there is no need for a further employment) and dealing with the hygiene issues. As this location seems to further reduce the costs, in the same time has the disadvantage of requiring building a new facility in the pharmacy. 5. Entrance to shopping center This location was suggested by a number of 10 people interviewed. While asked to indicate a better location alternative, more suited to their needs, these persons have asked why this kind of location has not been taken into consideration. They argued that in this way TeleMed would have a bigger market, as the number of people going each day in a shopping center could prove to be significantly higher than the number e.g. going to a fitness center and people could take a few minutes before starting the shopping to perform the tests. While asked to present their opinion about hygiene issues in this kind of location, 6 of them claimed that the reputation of TeleMed could be “inherited” from the shopping center’s reputation, and while there is precise indication about the tests, hygiene should not pose a problem. The remaining 4 were not able to present a clear opinion. While thinking about strengths of this location, the most interesting one is the way TeleMed could complement everyday shopping. As this is not an obvious situation, it should be somehow explained. As TeleMed offers weight tests (and calculating the bio mass index) as well as offering nutrition information under the form of e.g. diets, it is a possibility that TeleMed could influence your shopping habits, turning to the so-called healthier food. In the same time, it makes sense to question the efficiency of including tests involving blood in a shopping center. Here, TeleMed would be dealing with similar issues like in the case of the fitness center. The shopping center’s management should be convinced of the advantages of having TeleMed there and maybe allocate persons to help out with the tests. As there are a number of persons employed in the shopping center, this eliminates the need of employing new personnel, but does not eliminate the need of investing in training some of the staff members. These persons will not have to be around the machine the entire day, but he/she could be called by a simple button press, soliciting help. Other similar features involve increased reputation – increased number of persons going into the shopping center, which can easily be translated into increased revenues, revenues that could be used in building the separate room for the TeleMed. If you are just planning to use the TeleMed, while not make some shopping after that? And if you just came there to do your shopping, why not see what TeleMed has to offer? Let us now analyze the answers and the graphical representations. The graph below shows the attractiveness of different locations. The locations indicated in the charts are only the initial locations, presented in the questionnaire. From the graph we can conclude that the most popular location among all participants was at a doctors’ office (115 persons interviewed approved this location). When asked about the reasons behind this choice, the responses included trust, trained professionals, the possibility of contacting a doctor immediately if something is wrong and the help that could be provided by nurses. The second choice as a location was the hospital, with very similar reasons as in the case of choosing a doctor’s office. The questionnaire revealed that 74 participants were interested in this location, but in the same time they have indicated the doctor’s office as a second best option. 33 Location 140 115 120 100 74 80 56 60 40 20 0 Fitness Center Hospital Doctor Figure 9: Location It is also important to mention some of the reasons presented by the interviewed persons regarding the unwillingness of placing the TeleMed in a fitness center. Younger persons (in the 20-30 and 30-40 category) accused the lack of hygiene in this location, while older persons (above 50 years old) stated that by not usually going to a fitness center, they would not start going there only because of TeleMed. Another aspect that is worth mentioning is related to younger persons that do not usually attend a fitness center. Some even claimed that “going to a fitness center is stupid while you can just start running”, while others stated they would feel rather uncomfortable in going to the fitness only for TeleMed. Unwillingness of seeing TeleMed in a fitness center is also reflected in the graph above, having only 56 persons indicating interest in this location (mostly only young people-from the categories defined above). Among the reasons presented when choosing the fitness center the most popular was unwillingness to go very often to a doctor/hospital. The graph below shows the results for the question “How often would you use TeleMed?” Usage of the machine 70 61 60 50 36 40 30 26 35 22 20 20 10 0 Weekly Monthly Every third month Every half a year Once a year More rarely Figure 10: Usage of the machine 34 The differences in responses concerning this question were somehow hard to pin-point. The differences are not so big between alternatives, the biggest difference being between the “every half a year” and “more rarely” (41 votes in favor of the former). Nevertheless, the majority of people stated that they would consider using TeleMed every half a year (61 persons), not far being situated the number of people that would use TeleMed every third months: 36 people and the number of people that would use it once a year (35 persons). What was somehow surprising was the fact that 26 people claimed they would use it weekly and 22 people would use it monthly. Analyzing the category that stated that they would use TeleMed more rarely, out of 20 persons, 10 would use it when they would experience some kind of medical condition. Analyzing the presented data could lead to the possible hypothesis: depending on the reputation that TeleMed gains, people would immediately move from one category into the other, which makes it increasingly hard to present a qualified guess. Which tests 120 112 108 104 105 100 80 80 60 40 20 0 Blood samples Test of lungs Height/weight Information on nutrition and training Infomation on symptoms Figure 11: Which tests The next graph to be analyzed is the one that presents choices concerning the kind of tests people would feel comfortable taking when using TeleMed. The tests were explained as detailed as possible without trying to influence the outcome. What the graph above shows and might be interpreted as a surprise is the willingness of people of using the TeleMed for blood samples. Actually, most of them claimed they would use TeleMed for this feature (112 persons). It is fair to observe from the graph above that people are interested in all suggested tests and there are only slight differences between options. More than half of the interviewed people showed interest in taking all tests available in TeleMed. 108 persons were interested in the lung tests, 104 were interested in checking their height and weight, while 105 would check for information about nutrition and training. The capability that seems somehow as least appealing to people was the possibility of reading about symptoms. One reason would be the vast information already existent on e.g. the Internet even though that 35 information could prove to be insufficient or insufficiently controlled and checked (excluding sundhed.dk). Trust in technology 100 92 90 80 70 60 47 50 44 40 30 20 14 10 3 0 Completely Above average Average Below average None Figure 12: Trust in technology Telemedicine relies on communication technologies for dealing with medical conditions. This short definition leads us to another question: Are people willing to trust technology and the outcome of the tests performed in TeleMed? In order to find out the answer, we have asked people this question allowing them to choose from the following options: completely, above average, average, below average and none. A short explanation over the possible answers is therefore required, explanation that was also presented to the persons interviewed. By choosing completely, a person admits that he/she would regard the results returned by TeleMed with complete confidence, using them as parameters of their medical condition. An above average answer suggests that the results are to be taken into consideration, but in the same time having in mind that they could be wrong. The “Average” option is to be understood as an option of a person who would use the machine but not take the results seriously; relying more on a classical doctor’s appointment. The “below average” answers suits a person that would use TeleMed out of curiosity more than for the benefits provided. The interview showed that the majority of the interview participants, 92 to be exact, do not have any kind of problem in trusting the results of the tests, taking them as serious as possible. The results showed that there is a thin line between average and above average which could again be related to the reputation that the machine builds. 47 persons stated an above average trust while 45 persons have an average trust in TeleMed technology. The results of this question are in strong relation with the economical situation of the country, admitting that the citizens of a more developed country (like Denmark) would be more willing to embrace the 36 possibility of using TeleMed. Only 15 people would prefer a usual doctor’s appointment instead of TeleMed, considering using it just out of curiosity, while 3 persons claimed resilience in accepting that technology of this sort could ever replace or complement the regular check-ups. One of these 3 persons offered additional reasons: the conversation with a doctor cannot be replaced by heart-less technology. It is important to mention that these answers were given out of free-choice, as at no moment in time did we try to suggest that TeleMed could replace the check-ups. Doctor's visit 120 100 80 60 40 20 0 Weekly Monthly Once every half a year Once a year More rare Figure 13: Doctor's visits The last question addressed to people concerned how often check-ups are being performed. We have decided to ask this as a final question, as there was no intention in giving the impression that TeleMed is aimed at replacing the regular check-ups, but more at providing a complementary alternative. The questionnaire revealed that close to 50% of the interviewed persons perform the check-ups as often as considered sufficient (every 6 months) while the rest waits for a year or more. Out of the interviewed persons, 43 admitted they set up a doctor’s appointment only after they are becoming aware of a medical condition that they are experiencing. On the other side lay the persons that are extra-cautious about their medical condition, setting up appointments weekly (1 person) or monthly (9 persons). To illustrate the patterns of how TeleMed can improve the check-up rate in the Danish society the comparison beneath has been made. The second half of the illustration (“once every half a year” – “more rarely”) shows similar patterns, but the first half of the illustration (“weekly” – “every third month”) shows a considerable increase in the number of people willing to use the TeleMed machine compared to ordinary doctor check-ups. The conclusive matter is that the TeleMed machine can improve the intended prevention of the general health by more regular check-ups. 37 70 60 50 40 Usage of the machine 30 Doctor's visit 20 10 0 Weekly Monthly Every Once Once a third every half year month a year More rarely Figure 14: Comparison of Usage of the machine and doctors visit Overall: The point of this questionnaire was to determine first of all if there is a market for TeleMed and if people would show actual interest in it. There were issues concerning location (which is tightly connected to hygiene), trust in technology and willingness to perform tests available in TeleMed. Overall, we feel the results of the questionnaire are favorable, as from 200 persons only 3 seemed truly pessimistic and questioned the future success of this kind of machine. We are convinced that people understood the message that TeleMed is not aiming at replacing the usual check-ups, but is aiming at complementing them, making life easier for people while contributing to the improvement of their health. The questionnaire reflected that the short period after deployment of TeleMed would be critical for the future success (as this would be the period in which reputation could be gained or lost, which in turn would lead to an increase or decrease in the number of people using TeleMed and relying in the results). As it can be concluded from the answers given to the question related to location, people are aware of the hygiene issues and expect an overcoming of these issues before starting to use TeleMed. It appears people are convinced that by deploying TeleMed in a doctor’s office or a hospital many of the presented issues could be overcome. Also, the questionnaire reflected one aspect that the team was not expecting – even people that could be experiencing medical problems would use TeleMed (this could be interpreted as an unexpected result as TeleMed focuses on a preventive approach rather than on a curative one). Furthermore, another very important question that got answered after this questionnaire was the willingness of performing blood tests in TeleMed. The answer was more than positive, as the blood tests were the category most indicated as “to be used” by the interviewed persons. One reason for this could be the speed of presenting the results to the users. 38 Chapter 3 3.1 Introduction to our infrastructural ideas In chapter 2 the current status of telemedicine in Denmark was presented, the void that TeleMed could be filling has been identified and the perspective of potential users has been analyzed through the help of the questionnaires. There is a demand for TeleMed on the market, but this is not enough in order to assure the success of this project. A successful project means being able to offer proper answers to the questions formulated in the following lines - A complete and thorough analysis includes, in the first place, considering the financial aspects – what is the cost of TeleMed? Is a pilot a viable alternative before deploying the actual TeleMed and who could play the role of the investors? There are some that claim that introducing more and more telecommunication technologies into medicine will have a major impact on the human infrastructure and on the role that the patient is going to play in this new paradigm [Itkonen, 2003]. How does TeleMed change the standard relationship between doctors and patients? If we can conclude that this relationship is going to go through modifications, will the medical staff be willing to accept the new situation? One of the worst possible scenarios is the one related to doctors not accepting TeleMed as a viable solution in their work. It would be wrong to assume that once deployed all the problems and issues that TeleMed could be undergoing until then are over. There is a need of constant change in order to keep up with the demands from the market side. This leads us naturally towards the change management sub-chapter, where the focus is going to be on the way that a request for change comes to life and the steps taken all the way towards the Change Advisory Board (CAB). A change could be triggered by a number of causes – new technological developments, legislation change or issues signalled by customers. All these possibilities need to be addressed in the form of a Request for Change (RFC). The TeleMed project is focused on users/patients which mean that their opinions should always be taken into consideration. Before deploying TeleMed, customers needs have been determined by a questionnaire. How can a similar approach be accomplished after deployment? This will be the role of the Service Desk – assuring the users/patients questions, uncertainties and demands are listened to and further on, taken into consideration by the CAB. TeleMed is going to be a telemedicine application that will deal with personal information from a number of patients – the need of assuring the best security needs to be addressed. Questionnaires have revealed that the citizens of Denmark have an above average trust in technology and for this trust to be maintained, TeleMed will need to incorporate strong security policies. Patients, as well as doctors, will have the right of checking their information remotely, from any computer, over the Internet – security threats need to be mitigated and a viable web-based solution needs to be determined. All the points mentioned before would have no value without a thorough analysis of the legislation – is TeleMed going to need laws being changed or does the present law system permit immediate deployment of our project? 39 3.2 Financial infrastructure Innovative ideas are often built upon a good portion of optimism. An idea may often seem to be brilliant in the beginning but then get shut down due to expenses that were not foreseen. The gap between coming up with a good invention and becoming an entrepreneur is often the ability of financing and understanding the investments needed [Manove, 2000]. Performing an exact calculation of the investment needed in order for a project like TeleMed to get started is difficult. Many indirect costs need to be kept in mind (costs that are not directly connected to technology). Only estimations can be introduced and many unexpected expenses will be facing the board in charge of the project. This chapter introduces the way the financial infrastructural part of the TeleMed machine will be planned and approximately how much money is needed. This chapter shall be looked upon as drawing a picture of the financial matters and explaining the economical constraints, but not as a detailed economical calculation. For further economical details the project needs more time and many numbers are therefore build on assumptions. The chapter is nonetheless interesting to make clear how the project is planned to be run economically and clarify what the board needs to keep in mind. First of all, it is important to emphasize that the economy will build a lot upon transaction costs. A lot of information is needed, technical components needs to be purchased and further research which already exist should be used, and the cost related to making these deals are all transaction costs. Other areas are completely new and need to be build from the ground – e.g. pilot studies, maintenance and development of a database-system. The different expenses are described step by step. 3.2.1 Transaction costs Transaction costs is a term derived in 1937 [Coase, 1937] but might still need some explanation in this context while the term have different definitions. The definition in this report is as explained below by Demsetz [2003]: “A transaction cost is the cost of making an interaction when an economic exchange between parties takes place. It differentiates from production costs by only dealing with information necessary to coordinate processes”. Put in other words, the transaction costs cover all costs regarding making business with use of agents and employers workforce. There are different kinds of transaction costs that TeleMed needs to keep in mind: Search and Information costs: This cost relates to browsing the market for needed products and comfortable prices, a natural action from a company looking to keep costs down. In more details, it can be costly to acquire information, searching for a longer period of time for information, understanding the information [Smith et. al., 1999] and to discover bounded rationality (limitation of 40 decision-makers’ knowledge) [Williamson, 1981]. It is often the first step before going further to bargaining costs; Bargaining costs: This refers to the costs spent making an agreement with other companies or interests, and is often combined with contractual bindings. It can be seen as an exchange of demands of two (or more) interests [Hessel, 1981]. Bargaining costs are also referred to as decision making costs. Policing and Enforcement costs: Policing costs refer to the costs making sure that an agreement (contract) is being kept, which is done by safeguarding against opportunism (people acting after own interests), while enforcement costs are the ones of the action taken if the agreement is not being kept [Dyer, 1997] (by engaging rightful legislation). After having clarified transaction costs it is now possible to analyze examples of how TeleMed is ought to use the different types. Many different scenarios can be put up where the company deals with transaction costs, but here three different scenarios have been chosen: 1. Scenario: TeleMed has information stored in the machine about nutrition advices. TeleMed will then have to use resources on where to gain the information needed. After the information source has been found, it would be feasible to keep the connection because of updates and therefore policing costs are needed to make sure the deal made is being kept. Naturally this demands a contract which has bargaining costs to make an agreement. This scenario shows three different types of transaction costs besides the cost of the information product itself. 2. Scenario: TeleMed needs another company to perform a one-time pilot study of the product. Again TeleMed will need to consider the money spent on identifying the right company to do the work. Bargaining costs will also be needed this time, but the policing costs will probably be low since it is not a continual process. 3. Scenario: TeleMed found the company to perform the pilot study, but the study was not fulfilling the contract. In this case most of the earlier mentioned previous costs are not needed, but enforcement costs are needed to go to court. It is difficult to calculate overall transactions costs since it is a very dynamic area with unsuspected turns. Therefore it is more feasible to make a fund available that should make sure the amount is covered. At least three persons will be needed (Three persons are needed since many deals will have to be made at the same time and different business educational backgrounds are needed) having a Danish average educated persons wage of 30.000 DKK each month for one year, making a total of 1.080.000 DKK. 41 3.2.2 Pilot Study A pilot study is vital before launching a product like TeleMed accessible for the wide population, to eliminate chances of fatal errors ruining the machine’s reputation and gambling with a patient’s health. The study tests the machine and tries to erase errors and find possible improvements [Altman et. al., 2006]. The pilot study will undoubtedly perform many RFC’s for the CAB in change management. It can be argued that parts of the pilot study have already been performed producing this report. The extent of the pilot study depends on the number of investors and how much they are willing to fund. Having said that, an economical limit should be stated which symbolizes the point at which the funding is enough to perform a thorough test, to make the machine suited for the launch on the market. To calculate the cost of the pilot study, it is necessary to point out what the study includes: - - Research from professionals (e.g. market analytics, lawyers, doctors) to have a second opinion besides the developers’ idea and to make a list of critical criteria’s, coming up with new ideas. Technical test pilots need to be performed to exclude all errors within the machine and the machine’s technical infrastructure. The machine needs a test period on the market. Normally in this period the machine will only be placed in one location in the country and be monitored for possible errors. To try to specify the price of a pilot study further it will be reasonable to describe the proceeding of the studies in details. ï‚· Different juries will be established to perform check-ups: o A jury consisting of different types of lawyer specialists will be established trying to challenge the machine while making sure TeleMed encompasses all legislation. o A jury consisting of different types of specialist doctors will clarify the validation on the performance of the machine – and contribute with possible future implementations. o A jury consisting of different specialist technicians hereby gaining knowledge on the performance of the database and well as components reliability and make sure the machine is reliable enough for daily regular use. o A jury consisting of economists/researchers to make sure the machine stays within the financial limits (budget). ï‚· The machine will be tested for various diseases and usage by medical personnel and one month per area tested is needed: o Month 1: Test of ordinary fit patient and RFID-patch. o Month 2: Test of patient with lung disease. o Month 3: Test of diabetes patient. o Month 4: Test of patient with a heart disease. o Month 5: Test of more minor diseases (e.g. high cholesterol and symptom information). 42 A board in charge of the pilot study needs to be established consisting of professors at a Danish University having knowledge in medical research but who are neutral regarding the project. The two parameters mentioned above (the juries and tests) can run at the same time having duration of six months. After the six months obstacles will be lined out, the machine might have to undergo changes – and if so, depending of the size of the change - another pilot study might need to be enabled or small changes might need to be conducted. Assuming that the TeleMed machine is being approved after the first pilot study the price of performing the test will be approximately: - - Given that the medical personnel for the monthly tests cost 80.000 DKK (two doctors attached) for each month, the price will be 400.000 DKK for the monthly tests. Given that the different five juries need six months to make a conclusion and that each jury consists of three persons attached having an average monthly wage of 30.000 DKK the overall price will be 2.700.000 DKK. Persons being tested will need a fair price of 10.000 DKK for participating (giving a 10 person test group being paid 1.000 DKK each). This calculation makes an overall price of 3.110.000 DKK. After this comes an estimation of the prices for performing the tests technically. Materials needed to build TeleMed, facilities, transportation etc is estimated at 500.000 DKK. The estimation of 500.000 DKK is based on an average of 30.000 DKK for rent of facilities (e.g. warehouses) each month during half a year, transportation costs including drivers, trucks and gas costing 50.000 DKK for half a year and finally 250.000 DKK for materials bought from telemedicine distributors, legal rights and test equipment. This calculation is making an overall price of 3.590.000 DKK. Nevertheless, to be economically responsible a reserve poll needs to be established for unsuspected needs being 500.000 DKK making an overall price of 4.090.000 DKK. The estimate of the reserve pull of 500.000 DKK is to keep risks of closure down. Unsuspected errors, obstacles or need of new material always pop up in the working process. The reserve pull should of course be refundable for the economical contributors. But before it is possible to test the machine it will be necessary to build to machine. Transaction costs, software developers and components producers need to be taken into consideration. Estimation of the prices is made below - Transaction costs have been estimated to 1.080.000 DKK mainly due to wages (see 3.2.1 for calculation). - Software developers will need six months period working alongside with the monthly tests earlier mentioned (having two employees working with an estimate of 360.000 DKK (given a monthly wage of 30.000 DKK)). The production will cost an estimate of 300.000 DKK by use of materials and cooperation with a software company giving an overall price of 660.000 DKK - The machine with its design and production should be possible to be done by four month with an estimate price of 560.000 DKK. The estimate is built on a design architectural agency paid approximately 100.000 DKK for the design, and a final production of the machine (after the several above mentioned steps) costing 460.000 DKK (based on three persons working for four month with an average salary of 30.000 DKK plus a fee of 100.000 to their company). 43 This leads to an overall price of 6.390.000 DKK. Finally the board needs to be paid. Three actors would be enough to be in charge over a one year period with an estimate of (giving a monthly wage of 30.000 DKK) 1.080.000 DKK. This leads to the conclusion of a final pilot study price of 7.470.000 DKK. In general, it will be important for TeleMed to make clear economic strategies keeping transaction costs in mind. It should also be included in the business model which types of partners TeleMed makes transactions with. 3.2.3 Cost of final launching The pilot study incorporates all fees for having a final product. In worst case scenario, the pilot study is being shut down due to major mistakes, but in that case it will hopefully be possible to change and perform another pilot study. But if the pilot study shows successful the product is ready to be launched. Therefore the before mentioned 7.470.000 DKK is the final calculation. However, the final calculation does not take future costs into account, such as maintenance costs and costs of implementing future supplements. These costs are hard to predict since it is a question of how intense the future owner wants to interact. 3.2.4 Investors The TeleMed project can only be launched by big funding but that is not necessarily a problem. According to lung specialist Lene Birket-Smith (participating in telemedicine projects) and telemedicine specialist Birthe Dinesen (according to sub-chapter 2.3.3), there are a lot of companies willing to fund telemedicine projects. The TELEKAT project actually had back-up investors according to Lene Birket-Smith. The TeleMed machine can expect funding from both the state and private companies. The state because it is a natural interest to keep the health of the population at a good level, and Denmark would get a good reputation introducing a ground breaking system like TeleMed. Private companies can have various interests. Some may have built up a foundation over the years to improve health care. Others may have commercial interests - or if being a major investor, getting percentages of the revenue achieved by the system. Others may invest with their knowledge or development of technical aspects of the machine. To give examples of companies that could have interest in the TeleMed machine, three possible examples are given: - - Ericsson: The Company mainly known for producing mobile phones makes a lot of different devices. E.g. heating systems which are one of many technical components needed in the construction of the machine. Aalborg University: Naturally the university has an interest in bringing ideas to life from its own labs. 44 - Rambøll: This Company helped financing the TELEKAT project and is one out of many companies that at first glance does not seem like a potential investor. But Rambøll works in many spheres and one is innovation of IT and telecommunication. 3.3 Human infrastructure Dealing with a complex system, one of the most important aspects that need to be analyzed is the underlying framework that enables it to work in a certain way. However, by using the term “infrastructure” in regards to TeleMed, as seen before, the purpose is to analyze all the different “pipes” that create this new telemedicine system. This now leads us to the analysis of the ways in which a patient and doctors interact and how this interaction is going to be changed in regards to TeleMed. By implementing TeleMed, there are two main groups affected; the medical staff and the users of TeleMed. It can be argued that because of the technological development, the standard doctor-patient relationship will undergo some radical changes. In [Itkonen, 2003] it is claimed that “the knowledge gap between patient and doctor is so wide that diagnostic reasoning is inherently opaque to the patient”. This could be further understood as a minimal impact or participation from the patient side in the diagnostic process. Can TeleMed shorten the gap while involving more the user in this process? Digital documents in health care EHR e-Signature Results need advanced knowledge Contacting specialists Changing the standard relationship doctor-patient Patient needs to be informed about the contacts made Patient should be allowed to present their opinions Figure 15: New relationship doctor – patient At the current moment, only the personal doctor has the right to view the records of a patient (for the legislation issues, the reader is welcome to read the 3.7 sub-chapter). But TeleMed encompasses a number of tests and the results provided by the respective tests could turn out to need specialist knowledge (e.g. the lung test). At that moment, the user needs to accept the fact that the doctor is going to ask for a second-opinion and maybe present parts of the problem (meaning parts of the patient’s records) to a 45 specialist. If this is the case, the current procedure needs to be changed, as the doctor should inform the patient about contacting a specialist. In turn this means that the patient should be entitled in discussing the proposed action points with the doctor, thus gaining an active role in the diagnosis and treatment procedures. In [Itkonen, 2003] it is actually claimed that the autonomy will be moving to citizens by technology deployment, but this could be argued. One of the reasons presented is that by developing at the current rate, technology will provide new means for the patients in receiving information – this could be the case for TeleMed as patients can receive symptom related information, nutrition programs as well as immediate results for e.g. lung tests, blood tests, etc. It is only fair to admit that this approach could pose different problems, as doctors might be reticent. The success of TeleMed relies, among others, on the ability of the doctors of accepting this new paradigm. In order for this to happen, doctors need to be convinced that the benefits on their side could overcome this possible obstacle. Also, for the doctors the introduction of TeleMed could lead to changing some of their routines and procedures as they will have to take into account the time allocated to the TeleMed patients. What will the priority granted to them be? A straight answer to this question seems to be somehow out of reach as it depends on a number of factors like how many users are going to access the system and how many tests are actually performed. A possible way of handling this is to create an automated system that sends out notifications to the doctor after tests are performed. In this notification the results should be present, as well as other important indicators. At the end of the day, the doctor could analyze all the tests performed during one day and check if any of the cases needs detailed analysis during the next days. What changes does this new paradigm involve on the user side? Could a patient use efficiently the autonomy that [Itkonen, 2003] speaks about? Again, this question cannot be granted a straightforward answer. It is in the first place debated if the patient should have the right of not sending the results of the tests to his/her electronic health record. This leads the discussion towards the capability of the users of determining which information is of high importance. The safest way is to send all the information to the EHR, even if this means an increase in the work load for the doctors. As illustrated in Figure 15, when the test performed with TeleMed are followed by a consultation, the user will and should have the possibility of presenting their opinions, based on the information received on the screen of TeleMed. To conclude, we can state that one more important issue that will determine the final success of TeleMed will be related to the willingness of doctors in overcoming the obstacles of giving an increased autonomy to patients and the responsibility that patients are willing to assume. 3.4 Change Management After the illustrations of TeleMed’s infrastructure it is natural to look at what happens if changes occur in the infrastructure – especially in relation to the changes that already look appealing due to future inventions not yet on the market (See sub-chapter 3.4.2) When a machine like TeleMed is launched it is 46 vital to reassure the investors and the public that the machine is prepared for a range of obstacles and challenges and it is therefore necessary in this chapter to clarify who will be in charge and how a variety of situations will be dealt with. “Not every change is an improvement, but every improvement is a change” [Van Bon, 2005]. The term Change Management derives as a part of ITIL (Information Technology Infrastructure Library) and is not directly bonded to our field, but is still a term needed to keep in mind in this project to make sure who has the responsibility of decision-making. Change Management is a working function which clarifies the procedure of changes and performs agreed standards for the system to stick to. The standards (defined as the level of excellence required) followed ensures which groups needs to accept the change, dictates who should tests the consequences of the changes and who is kept responsible [Chapman, 2004]. Change Management can contain a variety of different strategies and be structured very simple as well as very comprehensively [Aladwani, 2001]. If a minor company launches a simple product the change management strategy should be kept simple (maybe only one director in charge of decisions) while major systems like introduced in this project needs thorough strategies encompassing all possible situations that may confront the system. Also, the TeleMed project will be sponsored by private interests, which makes standards for the boards decisions vital to avoid disagreement. 3.4.1 Clarifying needs of different management groups To clarify which actors are needed to keep a system like TeleMed running, the different groups needed are specified below. 3.4.1.1 CAB A change advisory board (CAB) needs to be established before launching the product. This body encompasses different employees who have the knowledge to analyze and predict the outcome of changes [Van Bon, 2005]. Generally, the CAB should be able to brainstorm and foresee the reaction given by change. The CAB should be able to eliminate wrong decisions and to keep a standard which excludes decisions contradicting policies of interest groups (e.g. the population’s interests, investors’ interest, the medical spheres’ interests, the governmental policies and legislations). To incorporate all interests the CAB for the TeleMed project should be established by the given actors: ï‚· ï‚· ï‚· Change manager: This leading actor will be described later. Service desk: The group needs a representative from the service desk in order to make sure that given changes are appropriate to the service offered. IT: To clarify the technical criteria being introduced by a change an IT responsible needs to be incorporated. 47 ï‚· ï‚· ï‚· ï‚· ï‚· Business manager: This will be more than one person. All actors who invested money in the project need to have their saying and also persons with economical background are needed to predict the financial aspects. Politician: At least one politician is needed to represent the policies given by the government. Medical advisors: A group of specialists within their own professional area should be established so a specific specialist can be asked for advice given a specific task. Lawyer: A lawyer is needed to make sure legislation is followed. Users: It is important to know the populations attitude and interest towards an upcoming change. The given actors above can reassure a decision-making process in favor of all concerned parts and stick to a standard which enables agreement and makes the highest chances of successful changes. The CAB is established to make sure major disagreement is avoided and to exclude fatal errors due to changes [Van Bon, 2005]. The change manager firstly mentioned in the CAB is naturally the person in charge of making the board-cooperate. Also the authority and responsibility of a functional board must be put on someone’s shoulders. Therefore it is vital that the person in charge is neutral and has leading capabilities. It is also the change manager’s job to decide when and how a change is implemented since the change manager has the overview of the project. Another aspect partial to the change manager’s job description is Request for Change (RFC). 3.4.1.2 RFC RFC is a serious matter that needs clear proceedings. In the future a lot of request and proposals for changes regarding the TeleMed machine are inevitable and it is the change manager’s job to filter these ideas, and decide whether or not the ideas should be proposed to the CAB. In order not to put all of the responsibility on just a person, and to avoid rejecting useful innovative ideas, a minor board of change coordinators of entrepreneurs has to assist the change manager in this area. 3.4.1.3 The final procedure So far, the change management for TeleMed can be illustrated as in this model: 48 RFC Change management and change coordinators CAB: Capable of accepting, planning, testing, predicting, evaluating and debating RFC's Figure 16: Change management for TeleMed But the model above only illustrates the internal level at the higher hierarchy in the TeleMed organization. RFCs are not just offered voluntarily or by coincidence and in order to obtain RFCs the organization will have to be aware of the sources offering RFCs, as illustrated in the model below: Incident Management Problem Management Service Level Management Availability Management Customers RFC’s Change manager and change coordinators CAB: Capable of accepting, planning, testing, predicting, evaluating and debating RFC’s Figure 17: Entities involved in the development of RFC’s 49 ï‚· ï‚· ï‚· ï‚· ï‚· Incident Management corresponds to the technical descriptions of the machine in two ways. Errors while using the machine are identified through incident management, but incident management also covers identifying future possible errors and is therefore a flexible ability that naturally offers RFCs. E.g. Errors in the database. Problem Management is closely related to incident management but concentrates on problems occurring and not exact errors. E.g. could be problems regarding opening hours. Service Level Management (SLM) is often a kind of analysis consultancy in close contact with the customers in order to make sure the product offered is still interesting. Often the CAB will send reports of their judgment upon RFCs and then SLM will perform an analysis. So SLM is also an entity with requests both to - and from the CAB. Availability Management is performing market research and researching new possible capabilities of the machine. It also works to improve the service offered and can be seen as a sort of idea developing faculty making sure than TeleMed does not surpass any opportunities. The Customers are in this case the patients and their opinions are of course of big importance for the changes being made. Yet again the information goes both ways since patients can make their opinions clear but the CAB can also draw contact with relevant questions [Van Bon, 2005]. Overall, all the above mentioned entities are not only built to suggest RFCs but they are also question answering entities that help the CAB choosing the correct decisions. The employees working in the different entities will not be full time employees but will mostly be governmental paid professors (or other professions with a relevant scientifical background) or ordinary citizens. 3.4.2 Setting up different scenarios and needs of change The earlier chapter defined the organizations behind the change management; now examples of how TeleMed would react in a situation where changes are inedible, examples in which changes the TeleMed machine are very likely to undergo (changes due to the future developments) need to be presented. 3.4.2.1 Change scenario: Blood chip The first scenario given is a situation that already is known to be a matter the management needs to decide whether to use or not in the future (See sub-chapter 3.4.2.1). The way in which the change management in the decision-making process will work regarding the blood chip is illustrated below: 50 Incident Management Problem Management Service Level Management Availability Management Customers RFC’s Request for information Change manager and change coordinators CAB: Capable of accepting, planning, testing, predicting, evaluating and debating RFC’s Figure 18: Decision-making process regarding the blood chip In this case the product/idea that needs analysis is an RFC which is already known, and the CAB does therefore not rely on RFC-making entities. Therefore the process starts at the CAB and at the change manager. It will most likely be the change manager asking the CAB to work on the blood chip. The CAB will then make use of the problem management entity, service level management and question the customers in order to make their decision. The request flow is therefore the opposite way around than if the product discussed was not known. This illustrates that change management is a flexible tool with the different stages of a process working together in all directions. In the case of blood chip implementation Availability Management is not needed since the CAB already knows the market regarding the chip as well as Incident Management can be excluded in the beginning since the product already is tested. 3.4.2.2 Change scenario: Legislation change But how about new criteria’s which are unexpected? Let us imagine that the government declares a new law changing the legal usage of finger needle tests, a change that demands TeleMed to change technical aspects of the tests performed in the machine. The process is illustrated below: 51 Incident Management Problem Management Service Level Management Availability Management Customers RFC’s Request for information Change manager and change coordinators CAB: Capable of accepting, planning, testing, predicting, evaluating and debating RFC’s Figure 19: Required steps for issuing a RFC The identification of the problem is most likely to be discovered by problem management and thereby made into a RFC. The change manager and CAB will then have to take actions, and by doing so they need advice from all the management entities to perform a justified change. This is the organizational process that will be most common since only a few RFCs derive from the beginning in the CAB, but are most often identified in the management entities. The flow of information in these cases starts from above in the model and goes down to the CAB (maybe stopped by the change manager), and then to make a proper answer the CAB consults the management entities that again answers back. 3.5 Service Desk It is impossible to design a service that proves to be flawless or a service that can please everybody. This is the reason why we are considering developing a Service Desk for TeleMed. The Service Desk is going to take care of the client queries, acting as a middle point between the clients and the IT administration. This way we are assuring that the specialized personnel does not receive low-level questions or service related questions and, on the other hand, we are assuring that the right IT person is assigned to take care of specific problems. It is because of this that the service desk is considered on its own a support provider. When considering all the entities presented in the Change Management chapter, we can establish the connections to the Service Desk. The first relationship that we need to take into consideration is the one between the Service Desk and the incident management. People that are using the Service Desk could present incidents or problems that they have encountered while accessing the services offered by the machine. One step that the Service Desk could take is to pass the information on to the incident management for analysis, under the form of written report. In the case that the incidents turn out to be of a serious nature, the incident management could consider formulating a RFC to pass on to the change 52 manager and change coordinators. In the Change Management the close relation between Incident Management and Problem Management has been underlined making it easier to conclude in this subchapter that the technical incidents signaled to the Service Desk could lead to formulations towards the Incident management and the non-technical incidents could lead to formulations towards the problem management. In connection to the role presented earlier on for the Service Level Management, the way to ensure that the product/service offered is still interesting could be achieved through the help of the Service Desk. People could receive different questionnaires about the services offered as well as they could receive information about modifications in the services [Van Bon, 2005]. Other questionnaires could be targeting the overall satisfaction offered by the TeleMed which brings us to the last relation – the one between Service Desk and the Availability Management. By deploying a service desk, the task of doing market research for other enhanced capabilities becomes easier. This responsibility of the Service Desk is not intended to be an annoying one, which can be assured by contacting only those users that explicitly allow this. For this to happen, in the moment of creating a new user account, the user is going to be explicitly asked if he wants to be notified of the newest changes or if he wants to participate in the future questionnaires with the perspective of symbolic offering of prices. The Service Desk could be a useful tool for the regular users as well as for the medical professionals. This last statement brings up a new question – is there a need to offer a differentiated Service Desk for regular users and for doctors? We tend to give a negative answer to this question, because of the communications media through which this Service Desk is going to perform its daily activities. The goal is to use communications technologies like the e-mail and phone which also makes the location of the service desk irrelevant. For example, there could be a number of different service desks placed in different cities, but because of the used model – a virtual service desk, they could appear to form a single unit. A type of Service Desk can also be incorporated in the TeleMed. While accessing the menu, a list of frequent asked questions and the answers for those questions will also be at the disposal of the user. If the user does not find the answer he is looking for, he will be encouraged to contact the service desk for any type of support. The goal of the persons working at the Service Desk should be to keep the satisfaction level of all the users the highest possible, a goal that could be accomplished by making use of procedures based on standard responses (scripts) [Van Bon, 2005]. We envision the requirements for the service desk as requirements for a call center, with personnel that is not highly skilled, having more of a dispatching function rather than an “any problem solving approach”, representing a middle layer between all the management entities and the customers. The reason behind not choosing highly skilled personnel is that we anticipate that most calls or e-mails sent to this Service Desk will not be related to the technical infrastructure, but more to the service experience. One of the last roles of the Service Desk is to take care of proposals for approving the maintenance contracts. Hardware and software, referring to the software patching (updating) or hardware replacing is also included in the Service Desk management. How can the overall effectiveness of the Service Desk be evaluated? For this question to be answered one must have in mind some performance indicators – the number of calls answered and the rapidity in answering, the number of calls that were dispatched to the IT administration and finally the number of 53 reports for the management entities in regard to the relations underlined in the first part. The Service Desk will be evaluated using predefined evaluation schemes [Van Bon, 2005]. 3.6 Security 3.6.1 Design and analysis of information systems – using XML as a unifying language When designing a system like TeleMed, we have to always keep in mind some aspects – what are the specifications, how it is going to be implemented and who is going to make use of it. For a short reminder, the following Unified Modeling Language (UML) can be used: Figure 20: Use case diagram And a corresponding use case diagram can also be presented: 54 Figure 21: Activity diagram There are a number of constraints that we come across during this process, constraints that can be of different nature. We can come across constraints related to rules or maybe constraints related to structure. When designing a complex system, we are addressing different categories of people. We could be receiving questions from business professionals or from system developers which means that we need to develop a common language for everyone [Blobel, 2003]. First of all, the viewpoints involved need to be separated. Each viewpoint has a specific vocabulary and meaning for the audience that it is targeting. Even though the viewpoints are separated, the viewpoints are not completely independent from each other because of some common terms that they could be using. To analyze a complex system, such as a telemedicine system, the ISO Reference Model Open Distributed Processing (ISO RM ODP) can be used [Blobel, 2003]. The ISO RM ODP divides the viewpoints in 5 categories: ï‚· enterprise viewpoint ï‚· information viewpoint ï‚· computational viewpoint ï‚· engineering viewpoint ï‚· technology viewpoint. The five viewpoints just provide the concepts that should be used and not the way to use them. As presented in [Blobel, 2003] the enterprise viewpoint focuses on the business specifications, business models and how revenues can be generated. The information viewpoint has as focus the information managed by the system as well as the structure and content of data. The computational viewpoint provides the means for dividing components into sub-components that interact over the specific interfaces. These sub-components that could be referred to as objects and need to be processed in a distributed way, which leads us to the next layer in the ISO RM ODP – the engineering viewpoint. The last layer in this so called stack of viewpoints is the technology viewpoint which presents the technologies used in designing the system. Providing an abstract overview of this type can prove to be very valuable considering that we just 55 need to instantiate each viewpoint for the design of TeleMed. To accomplish the task of illustrating these viewpoints, UML 2.0 could be used [Blobel, 2003]. Still, even if we use UML 2.0 we still need a way of connecting the different vocabularies used in the different viewpoints. The medical professional use a certain vocabulary characterized by usage of narrative text while UML just provides a means for graphical illustration. This is the reason that leads us to consider the Extensible Markup Language XML for connecting the viewpoints [Blobel, 2003]. But how can UML and XLM work together? The answer is considering the classes from UML and the relations between those classes as being paths and nodes in XML documents. In order to prove the connection between UML in XML while analyzing TeleMed, the following example was imagined – The UML portion shows four classes and the connection between them. A patient could access the tests (which lead to results), while the doctor class has the right to see the results of the test (as mentioned previously this is only an example, based on a small portion of the UML drawing, not taking into consideration all the possibilities). Figure 22: UML example using XML code XML sample for the above UML portion above: <?xml version="1.0" encoding="UTF-8"?>// Setting xml version and Unicode Transformation Format-8. It is an octet (8-bit) lossless encoding of Unicode characters. <schema xmlns:xs="http://www.w3.org/2001/XMLSchema" // In the schema we use the standard namespace (xs), and the URI, associated with this namespace, is the Schema language definition, which has the standard value of http://www.w3.org/2001/XMLSchema. <complexType name="Client" >// A complex type element is an XML element that contains other elements as we see below. The element’s name is Client. <sequence> // The following sequence denotes the characteristics of the client, as name (of type string, city, country and CPR. <element name="name" type="string"/>// Creating element Name for User full name input which consists of text (String). 56 <element name="street" type="string"/> // Creating element of street containing textual information of user street. <element name="city" type="string"/> // Creating element of city containing textual information about user city <element name="country" type="string"/> // Creating element of country containing textual information of user country <element name="CPR nr." type="NUMERIC"/> // Creating element of CPR nr. containing numerical information of user CPR number. </sequence> <complexContent> // The complexContent element defines extension on a complex type that contains mixed elements – we need to specify what are the rights of the client and the connection with the other classes <extension base="Tests"/> // The extension element extends an existing complexType element and “base“ specifies the name of a built-in complexType element. – in other words, the class Client has a connection to the class Tests. </complexContent> //this format marks the end of a tag </complexType> //this format marks the end of a tag <complexType name="Doctor"> // The following steps are performed again – we are creating a class called Doctor, class that has a number of attributes <sequence> <element name="name" type="string"/> //We are defining the name of the doctor and his profession (his profession is the one that gives him the access to the results of the tests <element name="Profession" type="string"/> </sequence> //this format marks the end of a tag <complexContent> <extension base=" Process/results "/> // The connection between the Doctor class and the results of the tests </complexContent> //this format marks the end of a tag </complexType> //this format marks the end of a tag <complexType name="tests"> //The final class is defined – named Tests. <sequence> <element name="Lungs" type="Process/results" //the class tests defines the list of tests: blood tests, lung tests, height and weight. The results are sent to the process/results class. <element name="Blood" type="Process/results" <element name="Height/Weight" type="Process/results"> </sequence> //this format marks the end of a tag <complexContent> <extension base="Process/results"/> // the connection between the tests and the results of the tests </complexContent> //this format marks the end of a tag </complexType> //this format marks the end of a tag <complexType name="Process/results"> //Finally, the last class is defined – the results of the tests, where a client could see his results. <sequence> <element name="Description" <element name="Results" </sequence> //this format marks the end of a tag </complexType> //this format marks the end of a tag </schema> //this format marks the end of a tag 57 The Client class is containing elements from the user’s personal information such as name, street, city, country and CPR number. This class is able to communicate with Tests class which is composed of tests such as lungs, blood and Height/Weight where 1.* indicates that one or more clients can access the Tests class, (there could be more than one TeleMed machines used at the same time). Furthermore, the Tests class is composed of Process/results class, which comprises the description of the selected test, how-toperform instructions and results of tests. The Process/results class can process one or more operations as indicated by the sign 1.*. 3.6.2 Security requirements for Electronic Health Records 3.6.2.1 Access rights, availability and integrity Until recently, ICT has been used in healthcare only for administrative and financial purposes. The change in the presented ecosystem has occurred in the last decades, when people realized the huge potential of including the health-oriented functionality of ICT in telemedicine and health care. Combining the two sectors is thought to have a number of advantages over traditional systems. But, if we are to be correct all the way in our statement, we have to consider the threats that this combination poses. One of the biggest problems of ICT is inherited security, which is accentuated if we take into consideration that health systems (and implicitly telemedicine systems) that use ICT are handling valuable information regarding patients. These systems involve the usage of Electronic Health Records, which contain sensitive patient data, data to which only intended professionals should have access. In the following paragraphs we are going to analyze the security issues related to TeleMed and the current situation of the Electronic Health Records in Denmark. To give an even clearer view of the formulated problem above, we are going to formulate the ICT requirements when using technology in the health sector. First of all, the problem of availability comes into place. In order to discuss this term one should in the first place define availability. One of the most comprehensive definitions seems to be the one provided in the Babylon Dictionary: “The degree to which a system, subsystem, or equipment is operable and in a committable state at the start of a mission, when the mission is called for at an unknown, i.e., a random, time. Simply put, availability is the proportion of time a system is in a functioning condition”. The task of providing a relatively accurate proportion of time in which TeleMed should be in functioning condition is not by far an easy one – claiming that 100% availability can be achieved would be a total overstatement. On the other hand, TeleMed will be dealing with data that are to be put in the electronic health record of the patient meaning the standard (threshold) cannot be set too low. One of the worst case scenario would be the following – after taking a number of the tests available in TeleMed, you might discover that a further appointment with a doctor could be necessary. Thus, you contact the doctor and set up an appointment expecting him to know about the alleged problem from the information submitted 58 through TeleMed. You had no idea that in the moments when you thought the information is being submitted the system was down. This is not an acceptable situation, as it leads to a time waste (you will have to take the tests again in the doctor’s office) and puts a stain on TeleMed reputation – there goes one user that is probably not going to use TeleMed ever again or at least, not any time soon. In the best case scenario just an estimate can be presented, estimate that could be changed during the pilot study. As reflected from the questionnaires, the best location for the TeleMed is in a doctor’s office. This means that TeleMed is available to the users in the working hours of the respective doctor – if needed, maintenance could occur in the evenings, after closing hours. The availability of the system refers to both hardware and software. One of the most used approaches while providing hardware resiliency is duplication of equipment. As this method leads to increased costs, we are not going to consider this as a viable solution for TeleMed, at least for the pilot study. If the pilot study proves the need for this kind of backup, duplication is going to be considered. In regards to the software availability, the situation here appears to be more acceptable as only copies of the software need to be kept. Mechanisms of backup need to be available for the valuable information with emphasis on the information stored in the databases. Backup mechanisms are of two types: full combined with incremental or differential [Preston, 2008]. In the full combined with incremental a full copy of the data is stored and successive incremental backups are performed. To recover in case of a failure, first the full copy needs to be restored and second, the incremental backup until the time of failure. In the differential backup, day to day modifications performed are saved. These mechanisms provide the means to protect against human errors or software failures. The second requirement is user identification and authentication. There are a number of ways through which this can be accomplished. First of all, there should be two categories of users – the patients (regular users) and the doctors. For the moment we are going to analyze only the login that takes place in the TeleMed room and return later to the login requirements over the Web interface. In the case of first time users, for logging into the system, the user will be asked to enter his CPR number and choosing a password afterwards. Referring to the password’s strength, different rules can be agreed upon e.g. choosing a password with more than 6 letters which also needs to have one of the following characters – numbers or special characters (?,.’ etc). The possibilities of logging into the system might be extended in the future depending on the progress of biometry (e.g. face recognition, finger-print recognition). One problem that could arise while using this system is related to forgetting to logout after using the system. This situation could lead to this problem – a user forgets to logout, the second user wants to use the machine and does not notice that the previous session was not properly ended. A possible mechanism to prevent this situation is the following – because the TeleMed is going to be placed in a special room, mechanisms like automatic logout can be installed as the door is opened. Of course, simpler mechanisms related to timeouts can be easily used from the technical perspective. The third requirement refers to integrity – this is related to the last aspect presented in the user identification and authorization. The worst case scenario presents a user filling up the EHR for another user by accident. The mechanisms presented above should be enough to avoid this situation. Last, but not least, the problem of access rights needs to be discussed. Who has the right to view the Electronic Health Records of patients and how much of these records are doctors allowed to view? This is a matter of critical issue that should be discussed after analyzing the existing policies in Denmark. 59 Each user that accesses the system needs to be granted a role which determines the amount of information that he is entitled to see. It will be assumed that only the assigned/personal doctor will have the right to view the information submitted through TeleMed. In case of emergency (e.g. the patient needs to be treated in a different region or by a different doctor), these rights have to be overwritten, with the doctor having immediate access to the records. For overwriting of these rights, the new doctor needs to present the reasons. The problem behind access rights becomes more critical when discussing a medical audit in case of a lawsuit concerning the EHR. The doctor needs to be able to prove that he has considered all the existing information and that his actions were justified. At first hand, this implies that all data needs to be time-stamped and that the possibility of recreating a situation from the past exists. In the same time, the possibility of keeping track of each and single access to the system should be provisioned. 3.6.2.2 Current situation of EHR in Denmark After going through one the European Union reports over the EHR implementation in Denmark, it is clear that a compromise regarding the standardization of EHR has not been reached [Rasmussen, 2009]. In the period January 1st 2003 – December 31st 2005 a number of initiatives were started in order to achieve implementation and development of the electronic health records. The primary focus was to develop standards and to achieve the integration of EHR with other IT systems available in the health care service. What was the outcome? Implementation of a Danish standard for EHR failed and this aim was moved in the 2008-2012 strategy [Rasmussen, 2009]. Given the present situation of uncertainty we can only present an ideal situation for adding the results provided by TeleMed to a future Electronic Health Record standard that is going to be modified depending on the outcome of the new Danish strategy. 3.6.3 Object oriented programming security for web based applications In designing a web-based solution there are several important requirements that need to be addressed in order for the TeleMed to be a success [Georgoulas et. al., 2003]: 1. The need for confidentiality – this is the first requirement for a secure communication over an unsecure environment like the Internet. Encryption could be accomplished e.g. through the use of protocols like Hyper Text Transfer Protocol Secure (HTTPS) and Transport Layer Security (TLS). 2. The need for traceability – as stated previously, in case of a medical lawsuit or medical audit, a doctor needs to be able to prove that his actions were justified by the situation at that given time so the problem of time-stamping arises. 3. Integrity – integrity refers to the possibility of discovering, before accidents happen, that the information at hand has been tampered with by unauthorized persons. Integrity also deals with reliable communication between server and client in terms of Digital Signatures. 4. Authentication – Before any communication of any kind can be conducted, there is a need for authentication. This is where the digital signatures (again) prove to be of the highest level of importance. 60 After analyzing the four points, we can go on to prove that the framework provided by the Public key infrastructure (PKI) is the one required for TeleMed. The PKI (which is more a security framework than merely a technical solution) with Trusted Third Party services is analyzed in the following paragraphs as a valid option for secure deployment of the web-based solution for TeleMed. The framework of PKI relies on the existence of certificate authorities (CA) or Registration authorities (RA) [Pharow & Blobel, 2003a], which register and issue certificates (digital signatures) for organizations, validating their public keys or which uniquely identify users. In simple words, the CA proves that organizations and users are who they say they are by performing some checks over their identity. A regular user of TeleMed would have to register with a Public Key Registration Authority while a doctor would have to register with Professional Registration Authority, assuring that after login they have the correct access rights [Pharow & Blobel, 2003a]. The Public Key Certificate Authority is the one that certifies the correspondence between the certificate and the user’s public signature, while the Professional Certification Authority has the same role for the professionals. Figure 23: Public key infrastructure So far, we have offered a possibility of determining the roles that users and doctors should play. The next step would be determining the access rights that each professional should have based on his specialization. This could be accomplished by issuing professional attribute certificates, even though the situation is far from being resolved because of existing discussions about how to describe specialties [Pharow & Blobel, 2003a]. The last requirement formulated above was related to traceability of different actions taken so that individuals cannot repudiate the existing information at one point, thus meaning that no one can change the creation date on the specific data. This task is accomplished through the use of trusted time-stamping, provided by third parties. How does this trusted time-stamping work? First of all, the requester of trusted time-stamping needs to calculate a hash from the data that he has at his disposal. The hash is sent further on to the trusted third party who calculates a new hash, by combining the submitted hash with a timestamp. The authentication comes by signing the new hash with the private key of the third party and sending it back to the requestor, who has to store the new data alongside the original data [Georgoulas et. al., 2003]. 61 Figure 24: Timestamp infrastructure After performing tests available in TeleMed, the user might want to verify that the correct results were uploaded to his Electronic Health Record or he might want to go through the results again. How would users and medical professionals get access to these Electronic Health Records? One way of verifying these EHRs can only be accomplished with the help of a Web interface. In the following paragraph we are going to focus on modalities of overcoming the threats of conducting medical communication over the Internet. Security can be implemented in different layers but here we are going to focus on the application layer. This layer supports a number of protocols with vulnerabilities that could be exploited, while combined with the fact that the most valuable information resides here make the application layer a desired target for attackers. One possibility of mitigating security threats would be to consider the benefits of object oriented programming (with focus on Java). What are the reasons for choosing Java? The primary features that have influenced this selection are interoperability and transferability, since programs can run on every operating system, without having to write the source code more than once [Deitel, 2004]. The Java platform allows the system users to define the rules that Java applications and applets (Java code that resides on the server and gets downloaded on to the browser whenever the client sends a request for the specific page [Deitel, 2004]) should comply with when running on their machine. Additionally, Java benefits of already implemented classes that accomplish the functionality required by PKI - in the case of the TeleMed webportal, an applet can consist of graphical user interface depending on the access right granted to the user, smart card controller (as an enhanced method of authentication), XML signing, XML processing and finally the communication using the TLS feature of Java and the data processing components as described in [Polemi et. al., 2000]. Let us analyze some of these components: A secure connection to the server can be established by using the TLS protocol which has a predefined API in Java – the secure socket extension [Deitel, 2004]. The TLS protocol establishes a secure connection between the client and the server providing strong authentication 62 and confidentiality using cryptography. TLS offers the possibility for unilateral authentication where only the server gets authenticated while the client remains anonymous as well as the possibility of mutual authentication – where both the server and client are authenticated by the corresponding side, which proves to be of greater value in this project. When using TLS, the client can validate the digital signature provided by the server. What to use XML signing for? Before we go into XML signing analysis we need to mention the servlets - the feature of Java that permits dynamic content on a website [Blobel, 2003]. The servlet could make use of the JDBC – the Java Database Connectivity API that defines interfaces and classes for writing database applications in Java by making database connections to almost any relational database – database that use tables to store information. The standard fields and records are represented as columns (fields) and rows (records) in a table to access remote databases and dynamically present content on the server web site (exactly the way we envision the Electronic Health Records to be). The next security aspect that needs to be taken into consideration is the communication between applets and servlets. A secure way of handling this communication could make use of the XML set [Blobel, 2003], including digital signatures, which provide the means of signing several messages at a time (this feature could prove to be extremely valuable while considering accountability issues – archiving the messages). Security can be enhanced by the so-called authenticode – which also uses the digital signature technology. Authenticode could be used to certify the origin of the software (having in mind that applets are downloaded from the Internet – unreliable sources) [HARP, 2000]. By signing code, the developer simply generates a digital signature string that is attached to the code. Summarizing the steps presented so far: Figure 25: Secure communication 1. The user uses his browser to connect through a secure connection (HTTPS) to the server. 2. Both the user and the server are authenticated using the TLS protocol 63 3. By accessing the web page, a personalized applet from the server side is downloaded into the browser of the client. The applet is personalized according to the credentials of the user, and implicitly his role. 4. The user authentication and the attributes provided will insure the fields in the database that the user will have the right to see only the right fields in the database. 3.6.3.1 Three tier architectural approach: Client server database By analyzing the proposed architecture of the TeleMed one can immediately see that we are proposing an server-client architecture, completed with databases. The difficulties of this three tier architecture clientserver-database relate to the way the information is presented to the client and the way the server accesses the database. The two things in question need to sustain a certain level of flexibility required for the best user experience because in the end it all sums up to the way the users have access to the information behind the database. In the previous subchapter we have seen how XML can be used as the unifying tool for the different viewpoints implied by the ISO RM ODP and how the Digital Signature feature of XML can be used in archiving and auditing messages, as well as facilitating secure communications between the applets and the servlets [Vlachos & Stassinopoulos, 2003]. When considering the OSI reference model, XML is one of the protocols used in the presentation layer and, in standard web applications architecture, it would be used for the representation of data in the client side. The capabilities of XML need to be “exploited” even further to the server side in order to obtain the desired flexibility [Vlachos & Stassinopoulos , 2003]. In the client side XML can be used to display the information, capability which could be translated in the server side as being able to locate information in a database. The desired flexibility that we have been talking about comes from unifying the two aspects under a common component. The web server is the one responsible for collecting information from the databases and presenting it to the web client, according to his profile. As mentioned before, in the client side an applet is downloaded in the browser while accessing the desired web page. In this presented scenario, the server needs to be able to obtain information from the various fields in the database and associate it with information provided from the client. To summarize things, whenever the user is logging in to the web applications (authentication performed in some of the possible ways mentioned before) the server needs to be able to access the correct fields in the database in order to present the correct information to the user, the user being a medical professional or a simple patient. A security aspect that has not been mentioned so far is the use of HTTPS while accessing the server. HTTPS makes use of the HTTP protocol while providing encryption and authentication through the use of TLS. 64 3.7 Standards/Legislation In this section, the Danish laws that could impact the final outcome of TeleMed are being analyzed. Since the word standard has different meanings, depending on context, it should be explained that in the following sub-chapter it is used in the legal way – referring to the standards established by law. It became clear after meeting blood specialist Kim Varming at Aalborg Hospital that blood samples were considered somehow a too radical innovation for TeleMed, because of the obstacles that blood samples could be facing. Nevertheless, it is still possible and we therefore needed to look into the prospects of blood measurement as a part of the machine and in that occasion make sure legislation could not turn down the project. After reading thoroughly through the Danish legislature concerning healthcare, which is influenced strongly by the rules of the European Union, it became clear that a lot of laws regarding this issue are not explicit and are substance for judgment in specific cases [Frank & Bix, 2008]. The next step was therefore to make contact with lawyers working with these specific tasks we needed information about. Two contacts were made; first contact made was to Anna Murphy who is a lawyer at Sunhedsstyrelsen in Copenhagen. Second contact was to Mikkel Dybtved Andersen working with legislation at Bloddonerne in Frederiksberg. Both persons agreed that performing a blood sample or finger needle test is easy and not much training is needed – nevertheless a doctor needs to authorize the person performing the tests, and it is therefore necessary to have a doctor included in the team (at least part-time) in order to follow the laws. This might sound too comprehensive for finger needle tests since no assistant is needed to perform the test, but the law clearly states that all kind of penetration through skin demands authorization from a professional doctor. In the case that e.g. a fitness instructor wants to perform blood samples the company behind needs statutory power and still a professional doctor assigned. As the Danish law (European Union law) is stated at the moment, the one being authorized by a doctor to perform blood samples is only seen as an assistant and not as an employee who is meant to perform several tests. This is due to the authorization law paragraph 17 which states that a doctor only gives authorization to an assistant if the use is limited, careful and is being kept on a fair level of use. For private companies like fitness centers to bend this rule special statutory power, which will be very hard to obtain, is needed. If the machine is located at a doctor’s office or hospital the doctors can obviously perform the blood samples and educated nurses are allowed to perform the tests as well. In general, due to the authorization law paragraph 74 part 2 which states that penetration of skin only should be performed by authorized doctors, the idea of locating the machine at a fitness center is hard to transform into reality. It will need special statutory power which will be difficult to obtain. The location of a doctor’s office is possible in the sense that the doctor finds the time to perform the tests himself or pass the assignment to assistants or hired nurses. There are no laws declining the nurses at a hospital location to perform blood samples. In the case of finger needles, there seems to be no serious preventions for any of the locations as long as a doctor is regularly connected to the place. 65 3.7.1 Standards that matter today 3.7.1.1 Fitting legislation in the infrastructure It is vital before launching a product like the TeleMed machine on the market to make sure laws are being followed. Within the infrastructure of the product it is important to make sure policy, privacy and authorization matters are not contradicting the legislation or Danish standards as well. Looking back at former Danish telemedicine projects proves that some of the biggest obstacles to overcome for the designers behind the idea were related to changing the current legislation. It is not always difficult to come up with new innovative ideas but the reason why it some do not get launched is often the country’s legislation. Examples of projects having a more or less simple idea where the main obstacle that needed to be cleared was legislation are: TELEKAT: This project aims to change the Danish legislation regarding who is allowed to get access to information stored from telemedicine patients, and legislation about who owns the data retrieved (See Attachment 3). MedCom: This project made it possible for the first time ever for patients to log on to their own medical record online. The project started in the county of Viborg in Denmark but is today available for the entire nation, and is a clear example of pushing the regulations [IT-borger, 2007]. This illustrates that not only does the TeleMed machine have technical innovations but also produces the need of innovative legislation. In order for TeleMed to be successful regarding legislation and standards, two different strategical approaches can be used: - Strategy 1: TeleMed is being launched encompassing the current legislation and is therefore possible to be launched immediately after the technicalities are cleared. This has the benefits of simplicity and certainty of usage, but its weaknesses are not to use the full capabilities technically possible. - Strategy 2: TeleMed is produced with features that currently do not follow the legislation and standards, but by political and medical debate hopefully will be approved for. This has the benefits of a more universal product possibly obtaining all the goals the design group aims for, but has the disadvantages of not being launched before the product is reproduced to be suitable for the given legislation. 66 3.7.1.2 Legislation that matters today In order to choose one of the two possible strategies given above, it is necessary to analyze if there are any laws challenging TeleMed. Due to the long list of various laws it is inconvenient to describe and clarify all of them; therefore this chapter only mentions laws which might raise problems for the implementation of the TeleMed machine. Law 1: As explained in chapter 2.3.1 the project has no issues regarding the medical procedures itself (unless ordinary blood samples (not finger prick samples) are performed), but the infrastructural information sharing related to privacy may confront the system. Basically all the information deriving from the patient is transferred to the patient’s medical record. The Danish legislation (dictated from EU directives) describes the medical record as a confidential document between the patient and the patient’s personal doctor [Søndergaard, 2008]. This law is not appropriate for the database-system ideas in TeleMed since it should be possible for the user of the machine to consult specialists directly, and these specialists will need the information given at the machine. This is a problem while the patient is showing his/her medical record to both the personal doctor and the specialist. In the real world it would not be a complicated matter while the doctor in an ordinary meeting would make contact to the specialists and give the information needed only. Figure 26: Needed situation This should nevertheless not be seen as a major problem while the currently running TELEKAT project is working hard to change the current legislation regarding this issue. Both the legislation but also the infrastructure in the hospital, because at the moment it is only possible to use one specialist from the TELEKAT machine, but with organizational and legislature changes, this can easily be solved – and the process of changing the law is already in progress. Law 2 Another law worth mentioning is a law which leads to a lot of sensitive cases regarding insurances. It is stated in the Danish declaration number 1373 of 16th of December 2006, § 8, topic 1, number 2b that the doctor needs to write a journal containing: - The reason why there has been a contact between the doctor and the patient. 67 - A description of the patient’s medical history. A description of the patient’s current condition. An explanation of the treatment given. This is not directly a problem, but is as mentioned a sensitive case in the meaning of authorizing the information. If a doctor stores the information in the database it should be kept certain by surveillance that the information is not changed, and authority should be given to law authorized personnel to enter the information during law suits, insurance questions and if a doctor in general is being claimed of performing a wrong treatment. Law 3 Some users of the TeleMed machine might find that they need treatment and through the machine make contact to a doctor. This is an infrastructural change decreasing bureaucracy and saving time for middlemen normally unnecessarily included in the ordinary procedure. One law defines a minor hurdle regarding the permission from the patient to perform a treatment. It is in the Danish legislation vital that the patient makes an approval either oral or by letter (for major treatments). But for the patient to give his or her approval in the TeleMed web-based application, it is needed to add digital signature to prove the interest of the patient. This can easily be implemented but is nevertheless important to keep in mind. 3.7.1.3 Changes needed for our machine to be launched It is of great importance to understand how medical records are proving materials for court trials etc and therefore needs to be handled with great care. But to look back at the before mentioned two strategies it becomes obvious that strategy 2 is the path to choose. It is not many laws that TeleMed does not follow regarding the infrastructural aspects. Only three laws restrict and one of them is already being challenged by another project while the later two are only a matter of few implementations in the infrastructure. It can be argued that we by the two implementations in law 2 and 3 follow strategy 1, but as long as law 1 is not followed, then strategy 2 is being used. The strategy to choose is therefore to believe in the importance of the product, meaning believing that the law system will show flexibility taking into account the many possibilities offered by the machine. An aspect worth mentioning that is not written in any law books is the ethical aspect. Ethical believes are hard to predict but when the machine has been launched there will undoubtedly be people with contempt towards the machine [Veacth, 1983]. These people may or may not have some correct ethical point of views, especially regarding privacy of people’s medical conditions, and if their believe is to be shared by the wider public – new laws against the TeleMed machine may arise. Naturally, the whole design process of the machine tries to eliminate the chance of this situation to occur, but it is still a possibility that needs to be kept in mind. Many telemedicine projects are “playing” with the legislation because a doctor is being kept responsible for the use of telemedicine products in private homes (e.g. TELEKAT). But with the TeleMed machine a doctor 68 is not attached to the machine unless the patient wants an appointment. The patient makes its own decision of using the machine and is therefore being kept responsible which eliminate many of the earlier known telemedicine obstacles, which shows to be a great advantage of the TeleMed machine. Currently telemedicine is a rather new subject in Denmark and the law is therefore not well defined which makes a product launch within the telemedicine field flexible in general. The most important law regarding telemedicine in Denmark is that the doctor offering telemedicine assistance finds the treatment reasonable and that the treatment is being given with care [Dons, 2005]. 69 Chapter 4 After making the framework for the TeleMed machine it became clear in which areas the machine can differentiate itself from competitive health kiosks on the market. The following are various techniques and market aspects that differentiate TeleMed positively compared to competitors. 4.1 Comparison of StayHealthy After researching in detail similar solutions offered by different competitors, we have reached the conclusion that the teaming between IBM and Stayhealthy seems the most powerful competitor. IBM and Stayhealthy have developed the so-called health-kiosk which we are going to analyze in the following subchapter. By analyzing the competitor’s approach there are some aspects worth mentioning: ï‚· Available tests: Stayhealthy and IBM – they are granting their users the chance to monitor weight, blood pressure and body mass index (BMI), as well as receiving information on fitness related products and services. The other tests offered are Blood pressure and pulse measurement, temperature, eyesight and hearing. Stayhealthy and IBM are also considering using in the future blood tests through the help of blood meter (e.g. blood glucose meter which is useful in monitoring a patient’s diabetes condition, requiring only 0.3 micro liters of blood). ï‚· Available tests: TeleMed - Currently the proposed architecture for TeleMed is incorporating all the aspects of IBM and Stayhealthy, having the advantage of a number of innovations. An innovative approach is represented by the blood tests performed with the finger prick (needle), as well as the lung test (Stayhealthy and IBM are considering this approach for a future implementation). It is obvious that both categories of tests need further clarification of hygiene issues before becoming feasible ideas, but while considering the finger prick this possesses the advantage of also offering information about hemoglobin and mononucleosis, and not only diabetes (blood glucose) still using a very small quantity of blood. The last innovation in available tests deals with the development of the RFID technology. Currently, RFID patches (e.g. glucose-monitoring skin patch, cardiac-monitoring skin patch, UV-monitoring skin patch, biomarker skin test patch) are available, patches which can be useful for persons desiring to gather statistics on their medical condition over a specific period of time. ï‚· Futuristic approaches – TeleMed is considering also incorporating the blood chip, also known as the lab-on-a-chip device. The current development in nanotechnologies must not be ignored. In the future, by using this blood chip, the waiting until results time will be decreased from days (normal blood samples) or weeks to only a few minutes [Genuth, 2006]. ï‚· Location – the issue of locations is related to national and regional preferences as well as legislation. The results of our questionnaires indicate that places like hospitals and doctor’s offices 70 would be the option of choice for the majority, while shopping malls and fitness centers would be the last option. Stayhealthy and IBM claim that their solution can be deployed in a multitude of locations, but after asking them directly about the public places in which this health kiosk can be deployed free of charge, they have mentioned universities and shopping malls. The innovation of TeleMed relies this time on the Danish system. By providing free medical care (which countries like USA do not), this permits our machine to be placed in locations like the doctor’s office or the hospitals, feature that the Health Kiosk from Stayhealthy and IBM cannot possess, as the intention of these manufacturers is to experience the highest profit possible. The kiosks available in universities are free for the users, but are paid by the universities, while the kiosks in malls are filled up with advertisements, which assure that the services are delivered for free (the StayHealthy approach). 4.2 Worldwide technical aspects related to TeleMed Infrastructure was the main focus of chapter 3 and it has been presented from a number of different perspectives – security, change management, finances and costs, service desk, human infrastructure and none the less standards and legislation. One can see, from reading what has been presented so far that the focus of TeleMed is within Denmark’s territory. In spite of this fact, there is a need to learn from telemedicine projects developed or being developed in other parts of the world. It is self evident that the focus of analyzing these projects is on a technical level, trying to understand the technical approach, regardless of other important aspects e.g. legislation that might not apply in Denmark’s case. To begin with, the first presented project is going to be the RESHEN project, a project that is incorporating regional networks from three different countries, namely Greece, Finland and Germany. The network in Greece consists of hospitals, health centers and infirmaries connected through a network, making the electronic prescriptions and referrals possible. The network in Finland includes several hospitals connected to a central hospital with the aim of exchanging electronic health records, while in Germany the involved entities have a focus on treating cancer patients by taking advantage of different knowledge levels. These three networks are inter-connected, thus permitting the medical professionals to exchange opinions in order for the patients to receive the best possible care. By analyzing the proposed architectures, it is becoming obvious that in RESHEN the Public Key Infrastructure has been chosen as a security framework. It is also worth mentioning that the certificate authorities chosen are accredited, national ones and secure databases have also been deployed. If one is to refer to the security chapter, one would find a number of other things that the proposed infrastructure of TeleMed has in common with this international project. XML- security is one of the aspects in common, mainly because of the world wide accepted standards. For a brief description of how the XML-security (e.g. digital signatures) is proposed for TeleMed, the reader can refer to the Security chapter (3.6). In a project that tries to make possible the interconnection of three networks from different countries, the issue of making use of widely available standards, which ensure interoperability, is of critical importance. Thus, the protocols being deployed in these networks fall in this category – the TLS protocol, XML digital signatures, 71 etc. While presenting the proposed security architecture for TeleMed, smart cards are mentioned as a possibility for enhanced authentication mechanisms. The viability of this idea is proved by the current deployment in the three debated networks. 4.2.1 The French System In chapter 3.6 the possibility of authentication by the use of smart cards has been brought under discussion. One of the countries that have adopted a model which includes smart cards is France. Even since the beginning of 2003 50 million cards have been issued [Kleinebreil et. al., 2003]. The mentioned cards confirm e.g. the social rights of the user. In regards to the health professionals, at the same date 0.5 million cards had been issued having encrypted information about the medical professional on it. The French model made use of specialized entities which certified the information on the cards and the level of specialization of the medical professional making use of it (physician, primary care or specialist) [Kleinebreil et. al., 2003]. One major disadvantage of introducing a similar system for TeleMed would be the high cost while the most prominent advantage would be overcoming security threats that are characteristic to digital signatures. 4.2.2 The Swedish System The deployed model (security wise) in Sweden was somehow different from the other models presented so far. The security of information was the main concern just like in the other projects, but in Sweden the government took advantage of the existing security infrastructure already deployed for banks. The starting premise for this approach was: “With no attractive eServices available there was no motivation for people to acquire means for eIdentification. With people not having means for e-Identification there was no motivation for government agencies to develop more advanced services” [Ribbegard, 2003]. Authenticating users could be a major problem (correct identification and costs) when it comes to a large population and since the banks in Sweden had an already existent solution the natural approach of the government was to take advantage of an existing infrastructure. Thus, one of the important healthcare projects that was going on in Sweden was the Secure IT for Healthcare Systems (SITHS) whose focus was the PKI for healthcare application, trying to determine, among other aspects, if a national agency should be chosen or several regional ones [Ribbegard, 2003]. As described in [Ribbegard, 2003] the outcome of SITHS was that users and healthcare professionals could be e-Identified by secondary certificates without the need of issuing special healthcare cards, taking advantage of the existing means of identifying users on-line by banks. The problem with choosing this solution was how to offer PKI services in an interchangeable way, delaying the process of introducing secure healthcare applications. 72 4.3 Lung test Another test which is considered to be integrated in the TeleMed machine is the lung test. In this part main aspects concerning how the test is performed are explained, what kind of diseases can be detected, and what devices could be used starting today to test the user. First of all it should be made clear what lung tests are used for. Lung function tests (also called pulmonary function tests) examine how well the user’s lungs work. The test determines how much air the users’ lungs can hold, how fast the user can breathe air in and out of the lungs, how well the users’ lungs receive oxygen and remove carbon dioxide from the blood. After the test the user gets an estimate on the lung’s volume. Lung volume is measured by the total amount of air the user can breathe out after a deep inhalation (The average pair of human lungs can hold about 6 liters of air and only a small capacity of this is used during normal breathing). Lungs volume can vary due to a lot of reasons; first of all, the best result is usually shown for 20-25 years old people and it also depends on sex and height as well. Secondly, men usually have bigger lungs than women and taller people have larger lungs than shorter people. Also factors like smoking or not and fitness make a difference in the volume [Booker, 2007]. So to keep these criteria in mind during the calculation, the user should be asked specific questions before, in order to assure a valid test. The primary device used in lung tests is the spirometry which will be integrated into the TeleMed system. Spirometry is always considered the first option when testing lung functions. For this kind of test the user breathes into a tube with a mouthpiece which is attached to a recording device. The user simply inhales deeply, closes the mouth tightly around the mouthpiece and exhales through the tube while measurements are taken. There are some tests where measurements are obtained by normal breathing, but some other tests require fast and forceful inhalation and/or exhalation. The volume of air inhaled or exhaled, and the length of time each breath takes is recorded and analyzed. In view of the fact that some patients may be sick, and for purposes of general hygiene, spirometer mouthpieces are designed for single patient use and are therefore disposable. They are manufactured and used in quite large numbers. Furthermore, mouthpieces should be in various sizes to make more suitable for e.g. children to use, to make sure the test is performed properly. As for lung tests performed on the TeleMed machine the user should after the test remove the mouthpiece and the next user puts on a new one - in case of the user forgetting to remove the mouthpiece, instructions before performing the lung test will be available, notifying the new user to put on a new mouthpiece on the tube if it is not new. Tests might be taken several times to make sure of the results correctness. Information is given on how to produce more accurate results before the test – E.g. the user should not eat heavy food or smoke for 4-6 hours etc. before the test [Bellamy & Booker, 2004]. Most common lung function values measured with spirometry are [Bellamy & Booker, 2004]: ï‚· ï‚· Forced vital capacity (FVC). This measures the amount of air you can exhale after you inhale as deeply as possible. This is the volume of air which can be maximally exhaled out of the lungs until no more can be exposed. Usually results are expressed in liters. Forced expiratory volume (FEV). This measures the amount of air you can exhale with force in one breath. The amount of air you exhale may be measured at 1 second (FEV1), 2 seconds (FEV2), or 3 73 ï‚· seconds (FEV3). FEV1 divided by FVC can also be determined, providing an important parameter in diagnosis COPD, as can be seen in table 6 below. Forced expiratory flow (FEF). Measures how much air can be exposed from the lungs. The quartiles are expressed as FEF25%, FEF50%, and FEF25%-75% of FVC. It is measured as liters/second or liters/minute. a) FEF25%: Shows the amount of air that was expelled in the first 25% of the total forced vital capacity test. b) FEF50%: Shows the amount of air expelled from the lungs during the first half of the forced vital capacity test. c) FEF25%-75%: This parameter measures the air flow expelled between the first 25% and 75% through an exhale. The pulmonary function tests represent a viable method in measuring the chronic obstructive pulmonary disease (COPD). COPD manifests when there is a limited airflow in the lungs and represents a chronic lung disease that includes two main illnesses: chronic bronchitis and emphysema (the air in the lungs is exhaled with a slower rate and smaller amount compared to a healthy person). The disease develops and worsens over time and COPD is not curable, but therapy can slow its progress. To make clear exactly how serious this disease is, it can be mentioned that in USA 12 million people are diagnosed with COPD and the disease develops over many years and is often caused by cigarette smoking [COPD, 2001]. When testing for COPD, the test results will be compared with normal value-tables with variables such as age, gender, body size to set the severity. The following table shows spirometric criteria for COPD severity recommended by Global Initiative for Obstructive Lung Disease (GOLD) [Bellamy & Booker, 2004]: GOLD Spirometric Criteria for COPD Severity I. Mild COPD * FEV1/FVC < 0.7 * FEV1 >/= 80% II. Moderate * FEV1/FVC < 0.7 COPD * 50% </= FEV1 < 80% III. Severe * FEV1/FVC < 0.7 COPD * 30% </= FEV1 < 50% IV. Very * FEV1/FVC < 0.7 Severe COPD * FEV1 < 30% or FEV1 < 50% At this stage, the patient is probably unaware that the lung function is starting to decline. Symptoms during this stage progress, with shortness of breath developing upon effort. Shortness of breath becomes worse at this stage and COPD exacerbations are common. Quality of life at this stage is gravely affected. COPD exacerbations can be life threatening. Table 6:GOLD Spirometric Criteria for COPD severity From the table we can see there are 4 stages to be concerned with. At first stage when showing mild airflow limitations which usually causes chronic cough, mucus production, and the beginning of damage to lungs, the patient may not notice the symptoms. The main advantage of using the TeleMed machine for 74 lung test is that the machine can detect the first stage of COPD. The second stage called moderate COPD is when the airflow is getting worse. The patient will notice symptoms like dyspnoea (difficult or shortness of breathing). At this stage the patient would usually go see a doctor for the first time. The third stage which is called severe COPD is when the patient has a very limited airflow. At this stage even simple physical activity as leaving the house or going upstairs can cause dyspnoea. And finally the fourth stage called very severe COPD is most critical in which complications such as respiratory failure and heart failure begins to develop. As an insight of what future developments in the lung feature of TeleMed can offer, here is listed a few alternative existing lung tests devices able to perform and detect diseases mentioned above. There are a lot of portable lung test devices available on the market, e.g. the below mentioned portable spirometers: ï‚· First one is called MiniSpir which is a portable USB spirometer [Medshop, 2009]. The most interesting thing about this device is that it can be connected to a personal computer through a USB port and it is using spirometer provided software giving the user the possibility to perform a large variety of tests. Some of the possibilities are measurement of lung age estimation. This device can also be integrated in the TeleMed machine quite easily as a future development; the only thing needed is software integration and a USB port. ï‚· Another lung test device which is more expensive and more powerful is called “SpiroLab III” [Spirolab, 2009]. This device offers FVC (Forced vital capacity), SVC (Slow vital capacity - amount of air you can slowly exhale after you inhale as deeply as possible [Bellamy & Booker, 2004]) and MVV (Maximal Voluntary Ventilation - the greatest amount of air you can breathe in and out during one minute [Bellamy & Booker, 2004]) tests with real time curves, high resolution color screen, fast but silent thermal printer and a digital turbine flow meter. 4.4 RFID-patches Including RFID applications in the TeleMed machine can raise different questions related to scalability, effectiveness and efficiency [Vilamovska et. al., 2008]. These aspects are closely connected to the following question: What is the biggest problem that could appear due to missed use or inappropriate use of the RFID application? Can the information provided this way be reliable and is it possible to offer RFID patches for free use? All these questions are going to be analyzed in the following chapter. One key feature of using the RFID technology is the possibility of automatic data collection and transfer. This could prove time-saving and error diminishing [Vilamovska et. al., 2008], considering a usual form processing time. The RFID tags could be classified in different ways, but the most usual classifications rely on: 1. Active, semi-active, passive tags. 2. Data storage/memory: read-only, read-write systems. 3. Frequency classes. 75 The RFID technology differentiates itself from other technologies by the capability of non-line-of-sight – the propagation of waves between the readers and tags even if there are obstacles on the direct path between them – in certain frequencies. One of the most used distinctions made between passive and active RFID tags is between active and passive tags, referring to the way the tags are powered. The passive tags have no power source of their own, requiring an external source e.g. the electromagnetic waves from the reader so that they can transmit signals [Vilamovska et. al., 2008]. This feature translates in long life but in the same time in a decreased range of communications (up to 5 m). To compensate this, the active tags make use of a battery which increases the range of communication but decreases the long-life capability, as the battery will eventually finish. In [Vilamovska et. al., 2008] it is claimed that although passive RFID tags are smaller and cheaper, active RFID systems are actually cheaper and easier to install. As it is going to be explained in the following paragraphs, our choice is going to be related to passive tags, as the cost-efficient solution could be achieved by using a reader-capable mobile phone. The second classification debated is related to the working frequencies. Long range, lowest cost, fast speed applications and highest susceptibility to interference (requiring line of sight communication) are features of ultra-high frequency tags (888–915 MHz) while high-frequency tags (13.56 MHz) have a medium range, a slower reading speed and are more expensive. The last category is the low frequency (<125 kHz) tags used for the most expensive, the least prone to interference and for the longest-range [Vilamovska et. al., 2008]. There are alternative radio frequency solutions like bar codes, Infra Red (IR), but without practical value in telemedicine. A viable alternative to RFID in telemedicine could be ZigBee, based on IEEE 802.15.4 wireless communication standard. ZigBee has a similar functionality to Bluetooth, allowing each node to relay the traffic from all other nodes (zigzagging from one to another). This capability proves its utility in a number of applications but in regards to the TeleMed solution, it adds no value. A kit for a person is going to be composed of just a small number of tags that are going to communicate directly with the reader, eliminating the need for every tag to relay the traffic from all other nodes. In the introductory chapters we have formulated the requirement specification for the so-called RFID tests. But what enables the wide-scale RFID implementation in telemedicine? The most important enablers are, as presented in [Vilamovska et. al., 2008]: 1. Better healthcare delivery - this can be analyzed from a number of perspectives. One perspective is the prevention feature, which leads to decreased costs. A second perspective could be the paperwork and manual activities which the RFID technology can address in a more efficient way. By incorporating RFID in TeleMed, the benefits of patient self-management at home appear alongside the possibility of collecting biometric data over a specific period of time. 2. Government support – our project is intended to be sponsored by a governmental force (alongside private money for pilot studies), thus in order for it to succeed, this support is regarded as an enabler of highest importance. The support from the government can be assured by promulgation of standards involving the RFID applications or by adoption of quality standards in national healthcare systems, which in turn can lead to scaling up capacity [Vilamovska et. al., 2008]. How can the RFID be implemented in a so-called “smart-way”? The smart implementation, as stated in [Vilamovska et. al., 2008] is associated with: 76 ï‚· ï‚· A well planned and successful pilot/demo Understanding of implementation costs - It appears to be a common belief [Vilamovska et. al., 2008] that the prices of RFID tags, both passive and active is dropping and will continue to follow this trend, alongside the complete RFID applications. The issue that is not agreed upon is the size of the cost decrease and the timeline, both being best characterized by uncertainty. In the present, the cost of RFID tags varies from 7 to 12 US cents, depending on capabilities and order size [RFID Journal (2009)], while the prices of the reader, accordingly to the RFID Journal “cost from $500 to $2,000, depending on the features in the device” (for UHF readers) and “High-frequency reader modules are typically $200 to $300” [RFID Journal (2009)]. Advantages of RFID tags – advantages are especially obvious for active tags (greater power, versatility and range), but we claim that the benefit of having a cost-efficient solution is greater in TeleMed, which means passive tags should be used. Also, in our view, already having a mobile phone that is able to act as a RFID reader leads to cost diminishing, as the RFID reader could be integrated in the mobile phone, with the cost of losing a part of the user-friendliness. This solution is very similar to the approach of Gentag, the company that has patented the use of RFID skin patch with a mobile phone reader. The other advantages of RFID tags refer to real-time data availability, ability to store more and encrypted information and userfriendliness. The next step after analyzing the enablers for using RFID in TeleMed is to analyze the possible obstacles that this solution could be facing. Costs play an important role in this paragraph, as well. We claim that the costs of deploying a RFID system can be decreased by using a mobile phone with reader capabilities, but this implies the respective patient already having the phone. This capability is not yet a very spread feature between mobile phones in the present, or at least among the usual category of phones (excluding smart phones), but according to Gentag’s forecast [Gentag (2009)], in the future one out of two mobile phones will be RFID-enabled. Another obstacle could be related to legal issues – without a legal standard that supports the RFID applications deployment could be made even more difficult. The security obstacles that could come across while using these tests are no different from the ones debated in the security chapter. The mobile phone is used in our scenario as a “middle layer” between the RFID patches and the machine, which eliminates the need for the mobile phone to send the information stored directly on the Internet and to the database. This means that no extra security patches should be incorporated in the mobile phone application, relying only on the security features provided by TeleMed. The third possible obstacle relates to technical issues like interference, reliability and interoperability [Vilamovska et. al., 2008]. By using passive tags, the range of communication between the phone and the tags is decreased which reduces the chance of interference. Reliability is accomplished by using a statisticslike gathering of data, like mentioned before. The interoperability issue seems the most problem-posing one, as the mobile phone of the patient should be able to read the information sent by the tags, independently of the tags manufacturer. 77 The last mentioned obstacle in the way of deploying RFID application for TeleMed concerns the patient’s acceptance (cultural and ethical concerns) as mentioned in [Vilamovska et. al., 2008]. For example, because of misunderstood security and privacy in some cultures and religions, a number of anti-RFID initiatives have already formed in different regions of the world, where RFID are considered “the sign of the Beast”, referred in the Apocalypse of John. Another misconception regarding RFID is the fear of ubiquitous surveillance, no matter what application is being deployed. Fortunately, this kind of reaction is not frequent in Denmark but still needs to be taken into consideration as a potential obstacle as it has the possibility of delaying the large scale deployment of RFID solutions in TeleMed. Patients need to be convinced that the data is not going to be misused and in the same time patients/users need to have trust in technology. Again, referring to the results of the questionnaire from chapter 2.2.1 the population of Denmark has an above average trust in technology which could lead to a rapid adoption of the RFID applications in telemedicine. In regards to the misusage, it is our belief (also confirmed by the results from the questionnaire) that for this to happen, TeleMed needs to gain reputation. This process can be hurried up by governmental standards for RFID applications and as well by public information campaigns, which could also help overcoming obstacles like citizens not being aware of the benefits of RFID. The security issue related to interception of the information stored on the RFID or phone by unauthorized parties can be addressed by encryption and authentication methods (explained in the security chapter). 4.5 Blood Tests Penetrating the skin of the patient without surveillance of a doctor is a sensible matter, but nevertheless it is a possible differentiation of the TeleMed machine. At the moment StayHealthy is not performing invasive tests but in the future they are planning on using blood meters – meaning finger prick tests. Which tests exactly is being kept a secret. The blood tests represent the most difficult subject to tackle. From a usual blood sample, a doctor could test a very broad list of possible illnesses. The blood is composed out of red cells, white cells and platelets [Boryczko et. al., 2003]. From red cells the hemoglobin concentration can be deducted which is useful in conducting investigations related to anemia, for example. Research in this field is an on-going work and thus the possibilities of diseases tested or maybe even prevented by blood samples is expanding each day. A simple blood sample could be taken in a few minutes in a doctor’s office and it’s the first thing that is tested during a usual check up. But what about those who are afraid/ashamed or maybe don’t have the time of going to a doctor for a simple check up? Our idea is targeting exactly those people, but is facing a big problem – the hygiene and legal issue (described in the legislation part). Think of a machine that could take your blood sample in just a few seconds – without having to wait for 2 days to set up a doctor’s appointment and provide results almost instantly. As interestingly as it may sound how can the hygiene issue be taken care of? It appears that Aydogan Ozcan, the head of the Bio and Nano photonics Laboratory at UCLA, came up with an innovation that bypasses these issues [Lemens, 2009]. Aydogan Ozcan states that most HIV patients are either in India or Africa and they do not have the resources (you can just replace “resources” by time in more developed countries) of 78 taking blood samples, sending them to a central lab and getting the counts back. His invention refers to a usual cell-phone to which a tiny glass slide that holds blood sample was added [Lemens, 2009]. This could be clear evidence that hygiene can be fixed in the short term future. But hygiene is not the only problem of ordinary blood samples. One sample is rarely enough to state clearly if a disease has spread in a body. E.g. a test for diabetes sometimes shows alerting values whereas the next two tests show normal values. Also, performing ordinary blood samples will be a major expense due to storage, at least if it will be possible for all of the public to perform the tests. Nevertheless, if future developments are being carried out in this field, it may show itself as a future prospect. For this project, we have searched the help of a blood specialist, Kim Larving. We have discussed the possibility of including finger prick tests in our machine but we were confronted to a very skeptical position. We feel that blood tests could be conducted by the use of so called rapid tests – like finger needles, tests that require several times less amount of blood. The problem with usual blood samples taken at a doctor’s office is due to the perspective of having a patient bleed too much or even having him/her faint. This is not a viable alternative if the machine is to be placed in a different place than a doctor’s office. With this in mind we have presented the idea behind the finger needle but the skeptical position was due to the supposedly lack of accuracy of these “rapid – tests”. Although this could be interpreted as a sign of shutting down the perspective of including finger prick samples and, further on, tests in the machine, the specialty literature tends to contradict this perspective. In the paper called “Finger-prick blood samples can be used interchangeably with venous samples for CD4 cell counting indicating their potential for use in CD4 rapid tests” by [Calman et. al., 2005] it is proved that the accuracy of these rapid tests is getting better and they point out the possibility of replacing venous blood tests by these rapid tests after the latter ones become more widely available. It is true that this research was conducted for tests over HIV and our project has nothing to do with this kind of diseases (we don’t have in plan a machine that could provide you with these kinds of results simply because of the psychological effect) but we should keep in mind the perspective or rapid tests that could add value to our innovative idea. Considering the finger-prick test, the level of blood sugar could be measured (helpful in the treatment of prevention of diabetes), the hemoglobin level that could be an indicator if someone is allowed to donate blood, and the mononucleosis test could be conducted with the obvious advantage of needing a small amount of blood – usually less than 500ug. These are the most acknowledged tests on the market of blood meters and other measurements seem unreliable. One other measurement that can be performed with a useful result is blood poisoning, but it does not seem feasible to spend money on testing something so rare. When blood meters at the TeleMed machine are being used, it is important to stress for the patient that the results given should be seen more as indicators than final results. Blood tests are complicated matters which often demands more than one test. E.g. diabetes patients (or people who want to find out if they have diabetes) often use glucose blood meters three times a day in order to find clear results. If patients want to test glucose values with TeleMed they will have to test themselves at least once a day and by use of the database (which could help in calculating statistics hereby making curves only giving indicators if the patients glucose is within the danger zone) the diabetes test can only be seen as a warning sign and final conclusions can only be drawn by making contact to a doctor, if the values gathered are critical. 79 Nevertheless, it is an important preventing test while the patient may not get tested before it is too late otherwise. By making contact to StayHealthy’s information manager John Collins it became clear that their main hold back for using finger prick tests is the hygiene. It is obvious that it is a major problem for their machine since it is located e.g. in malls where no medical assistants are available. With the TeleMed approach, having the machine at the doctor’s place, medical assistants can easily exchange the small needles from the tests and make sure no danger of transmission of diseases occurs. Naturally the patients using the tests may have their concerns of trust but it is a core intention of the machine to have a high reputation. Within the telemedicine field many papers stress the need for further availability of especially diabetes help. It is definitely a major improvement of the TeleMed machine compared to the StayHealthy machine with the usage of blood meters. 4.6 Realistic future changes 4.6.1 Iris laser test During the meeting with Kim Varming we were introduced to the possibility of performing laser iris-tests (Iris being the eye-ball). As clarified in this report eye-tests will be performed in the TeleMed machine but only traditional tests (stated in sub-chapter 4.3). The possibility of scanning the iris with laser exists and is already on the market [Diytrade, 2009] but has not yet been scientifically approved (though it has been on the market since 2004). Scanning the eyes with laser can show signs of black pigment, problems with blood veins in the eye, problems with tissue and other criteria’s, but as such lasing the iris does not produce results of the users visibility. The test can identify problems with the pupils but these measurements can be influenced by the density of light in the location where tested (A few iris laser test instruments can calculate the density of the light in correlation to the pupils, but the results are not detailed). Looking at other health kiosks on the market only dealing with eye tests such as SoloHealth, it became clear that other providers do not implement the usage of scanning the iris. It has been concluded that TeleMed will not make use of the option since it is not scientifically approved and therefore will be troublesome to launch while it will be time consuming to get a permission and maybe not even possible to offer to the public. Also, if a decent laser iris test should be performed an assistant is needed to make sure the user is placed correctly in relation to the laser. Dealing with laser can also give problems with injuries of e.g. diabetics (not able to handle the lights). An iris laser test show no more than what can be seen by an eye specialist by just observing the patients eye and it has therefore been decided that for the more detailed eye problems the iris-test deals with, a practical eye doctor is more convenient. Maybe future developments of laser testing will improve but at the moment it is not convenient as a tool for persons performing the test themselves. 80 4.6.2 Blood chip Starting from 2006 [Boothby, 2006] it became possible to perform tests by handheld microchips stating to which kind of blood group the patient belongs. This was especially convenient for patients who needed immediate treatment not being at a hospital in order for the surgery not to fail. It only took three seconds to perform the test and only demanded three microlitres of blood. As a follower the same year a new invention could show how many red and white blood cells the blood contained as well as showing infection, anemia, allergies and immune system deficiencies [Genuth, 2006]. Nevertheless, to be useful for the TeleMed machine more measurements than only which blood group the user belongs to and few other measurements are needed. This became possible last year (2008) by a new invention by James Heath [Jablonksi, 2008]. He, alongside with more professors, invented a new chip that within ten minutes can measure a variety of results. Some predict that the chip will even be used in ordinary doctor offices because of the fast result instead of having to perform a blood sample that needs to be analyzed and takes days. It only takes a single drop of blood to get results from the chip. Here is how the proceeding is explained: “…Starts the analysis process with some simple microfluidics. A drop of blood is pulled down a microscale channel by the application of a small external pressure. This first channel branches off into narrower ones, which exclude blood cells and admit the protein-rich blood serum. In typical blood tests, this separation step requires a centrifuge. The narrower channels are patterned with what Heath calls a protein bar code — lines of DNA bound to antibodies that capture proteins of interest from the serum. After the serum and cells are flushed out, antibodies bound to red fluorescent proteins are flushed in, lighting up captured blood proteins. The protein bar codes can be read under a fluorescent microscope or a gene-chip scanner. The identity of the captured blood proteins can be determined by the location of red lines in the bar code relative to a green fluorescent reference line” [Jablonki, 2008]. Figure 27: Blood chip [Svitil, 2008] If the possibility of performing blood chip tests at the TeleMed machine is offered, a scanning device is needed for the results to make sense for the user. Compared to an ordinary blood sample test a doctor would perform, the blood chip takes care of the following in the process [Toner & Irimia, 2005]: 81 Figure 28: Blood chip infrastructure Identification, separation and analysis are what is time consuming with ordinary check-ups which with the blood chip can be achieved in 10 minutes. It saves personnel and time and is a significant decrease of costs. This, alongside with showing more specific results, is what differentiate the blood chip from finger prick samples [Genuth, 2006]. As a whole, the idea of blood chips opens a gap of treasures of wide information on the body’s health since blood carries various information. The concentration of a dozen of proteins can be measured by the chip and signs of e.g. cancer and heart diseases can be detected. Nevertheless it would be more convenient to introduce in the TeleMed machine after the blood chips have been accepted as common use in hospitals, doctor’s offices and ambulances (needing immediate blood samples). Also ethical questions arise with the usage of the chip regarding TeleMed since the result may e.g. show cancer, and it can be argued that such a statement is not suitable to be informed at a machine – also one result showing cancer is not a certainty of cancer, more tests are needed according to blood specialist Kim Varming. It should also be mentioned, that even though the chip currently is working well it is still undergoing improvements being able show more results (up to 100 different proteins) and the scanning device needs to be more user friendly for an ordinary user to understand the information given [Svitil, 2008]. The blood chip has received confrontation since analyzing blood cells are a complicated matter, but critics seem to be unable to deny the usefulness of the chip. Nevertheless, being a ground breaking implementation for 82 medical treatment both for prevention and lower costs it will still be most appropriate to wait implementing the chip in the TeleMed machine. 4.6.3 Information offerings After a meeting with telemedicine specialist Birthe Dinesen we became aware of the importance of interviewing the users at the machine prior to a test. Before a user for example gets tested for lung diseases it would be important for the end results if the user is a regular smoker. Birthe Dinesen showed us telemedicine equipment which by a menu asked the user several questions before the tests were conducted. It all builds up to more valid results and better the users’ understanding of which criteria’s influences the health of the concerned matters. As earlier mentioned, the TeleMed machine contains information regarding the tests and information in general on e.g. nutrition, training programs and symptoms. At the moment, the biggest portal on the Internet in Denmark containing this type of information is Sundhed.dk. Sundhed.dk is owned by the government and since we expect TeleMed to be owned by the government as well, we recommend trying to make an agreement on information sharing as an effort to keep production costs of new information for the TeleMed machine down. This might be considered a setback for Sundhed.dk since it will decrease the portals importance, but TeleMed will only need very specific information whereas Sundhed.dk has many more offerings such as debates, archives and chat. Collaboration between Sundhed.dk and TeleMed can easily be engaged, but other Internet sources should be kept in consideration as well as alternatives. 4.7 Differentiation of the market We believe launching TeleMed in Denmark gives advantages. These advantages are difficult to state with sources since it is mostly assumptions of market mechanisms and cultural differences, but nevertheless it has been found an important improvement of the TeleMed abilities. One major difference between the Danish and American market has been mentioned in sub-chapter 4.1 clarifying the possibilities of making TeleMed free of charge not being possible in America. Current American president Barack Obama wishes to change the American healthcare system being rougher on the insurance companies and making it easier for the citizens to purchase insurance, but there are no signs of healthcare being free of charge [BBC, 2009]. But other criteria’s also influence the difference of having freely used options. E.g. Danish clients would most likely hesitate more on using a health care machine with commercials (which is the case with StayHealthy located in malls). This is a criteria making it easier for American distributers to make money, but it leads to a Danish advantage – the government would be likely to contribute mentionable on the production and maintenance of the machine, and therefore commercials 83 are not needed to the same extent, and the TeleMed machine can be located at places where commercials are not being as eye-catching, like at a doctor’s office. Denmark also has the advantage of being a small country, making it easier to build up a good reputation and to spread out information about the machine. This differentiation is of course only set in relation to larger countries. After having the meeting with Bjarne Flou (see chapter 5) it became clear that a quite similar project to the TeleMed project had been running in 2008 in Germany but had to close down due to lack of investors. Bjarne Flou nevertheless found the possibilities bigger in Denmark due to a rise of economical investments in telemedicine. At a political point of view many investments have been made building new hospitals etc, and it seems likely that the Danish government would be more eager to invest more compared to many other countries. Another factor is the TELEKAT project finding many private investors building up a secure economical base. Reviewing the Danish legislation it became clear that no major obstacles were endangering the project. It will be fair to assume that some other countries have privacy, medical or security boundaries making the project difficult to launch. Other factors e.g. insurances (or traditions of health care payments) makes Denmark easier to handle when it comes to launching a free of charge medical supplement. The only analogous machine to TeleMed, StayHealthy, deals with insurance difficulties on the American market. In Denmark no such factors are playing a role. Overall, Denmark has shown itself a country willing to take the first step globally in various areas, also within the medical sphere – and going on by having the first public freely available health care system does not seem unlikely. As mentioned, above information is build on assumptions and knowledge of market indicators, but it seems reasonable to have in mind. 84 Chapter 5 5.1 Interest shown in TeleMed Following the e-mail exchange with Bjarne Flou, managing director, interest from Tunstall Healthcare A/S has been shown in the TeleMed project. At the moment, Tunstall Healthcare offers a list of personalized solutions – medical kits for diabetes patients, COPD patients, etc. Apparently, Tunstall is receiving requests from places like nursing homes asking for a multi-user solution; requests that Tunstall feels could be met by TeleMed as our solution is not focused on a personalized list of test, but on a multitude of tests. A graphical representation would help to understand the interest of Tunstall better: Home with Diabetes patient •Kit with blood pressure, heart rate, blood oxygen level and glucose measurement test. Home with COPD patient •Kit with blood pressure, heart rate, blood oxygen level and spirometry Nursery home with TeleMed The solution here should not be personalized anymore and be able to meet the requirements of all users.ent Figure 29: Tunstall interest Why would this location be interesting? Because of the advantages offered –nurses in these facilities have to take care of patients, which means that the issue of performing the tests in the safest way and in the most hygienically way is being resolved through this approach. The deployment of TeleMed could take place faster as demands already exist for this solution. Our initial approach was aimed at obtaining public owners (meaning the government) but, if deciding to accept this offer it would mean that the investment would come from the private sector, turning TeleMed into a commercial solution. As discussed so far, the possible contribution from our side in the Tunstall project is going to also take care of integrating the hardware with Tunstall’s existing platform and is going to extend beyond the time this report is going to be presented. The first step for this collaboration would be finding equipment distributors in order to build TeleMed so the following sub-chapters will focus on distributors (e.g. A&D) and equipments. 85 5.2 Distributor In the search for a distributor it became clear that a variety of distributors are needed. Products like monitors and the skeleton of the machine can be whoever is willing to offer the smallest price. Many factories can offer these products and the choice will most likely be an option of price. E.g. the monitors can be from Samsung, Daewoo, Sony etc. but it does not make a big difference which company is chosen therefore the lowest price is decisive – if the quality is acceptable. This strategy was proposed by StayHealthy in e-mail conversation with John Collins. After browsing for companies distributing telemedicine components the most suitable company is A&D. The company is multinational and well-established since 1977. The company is a producer of advanced measuring, monitoring, controlling and testing instruments. The company offer a lot of the components needed in the TeleMed machine which have been clinically validated before sale. Other alternative companies, such as TelcoMed, are possible alternatives, but no one else seems to offer as many relevant components as A&D. StayHealthy are also using some components distributed by A&D – e.g. the TM-2655 showed below. Contact was made to business developer at A&D Frank Downing who provided information about the components functionality and gave some price examples. Here are some examples on components known to be relevant for the TeleMed machine: UA-767PBT-C40 – Blood pressure monitor. Price 810 DKK per unit. A minor device called UA-767PC is priced at 722 DKK per unit. Figure 30: Blood pressure monitor Features of UA-767PBT-C40: Bluetooth Class 1 CE0700 compatible 128bit encryption of data for protecting patients' privacy Higher compatibility with various Bluetooth receivers Built-in real time clock Irregular Heart Beat Indicator Extra large 3-line display for easier reading of results One-touch measurement SlimFit comfortable cuff TM-2655 – Fully automated blood pressure monitor. Price 9.824 DKK per unit. This machine is commonly used at hospitals and on the StayHealthy machine. It only takes few minutes to perform a test. 86 Figure 31: Automated blood pressure monitor Features of TM-2655: Compact size Light weight and either arm measurement One-touch measurement Large LED display Quick printout (on TM-2655P model only) Dual RS-232C ports UC-321PL – Weight scale featuring suitable software. Price 745 DKK per unit. A minor device called UC-321PC is priced at 581 DKK per unit. Figure 32: Wight scale Features of UC-321PL: 50g resolution Maximum capacity of 150kg Target weight setting 31 built-in memory function BMI Value Calculation Very low profile so easy to step onto scale UC-321PBT-C40 – Weight scale with wireless connection and a weight capacity of 200 kg (compared to the before mentioned 150 kg). Price 1.005 DKK per unit. 87 Figure 33: Wireless weight scale Features of UC-321PBT-C40: Bluetooth Class 1 CE0700 compatible 128bit encryption of data for protecting patients' privacy Higher compatibility with various Bluetooth receivers Built-in real time clock 100g resolution up to 200kg capacity Very low profiles Rugged construction Motion tolerance Kg / lb selection Regarding distributors it is a disadvantage with the relatively few distributors available on the market which may cause a rise in retail prices. As a strategy TeleMed should nevertheless always consider new distribution channels to keep costs low. Nevertheless the prices of A&D components seem reasonable, and if TeleMed make large orders from the beginning, the prices might even lower. 88 Chapter 6 Conclusion TeleMed represents a complex project, one that deals with a multitude of different aspects (e.g. medical, financial, technical, etc). Throughout this report, the need for TeleMed as well as the void that TeleMed could be filling on the market have been identified. Moving from the current curative approach that Telemedicine seems to be embracing towards a more prevention-oriented one is synonym to introducing a new medical paradigm. Following this path is not an easy task – questionnaires have revealed, among other things, that the success of TeleMed (measured by the number of people using it and number of times to use it during e.g. one year) will be conditioned by e.g. first of all, the reputation that TeleMed will be able to achieve and second of all, the security achieved in setting-up the web-based application. Reputation is going to be directly connected to the way hygiene issues will be mitigated (throughout the report, solutions have been presented) while the security issues have been dealt with, referring especially to the object-oriented programming sub-chapter. On the other hand, patients will not be the only users of TeleMed. Judging by this category of users, the success is going to be conditioned by the way TeleMed will be perceived by the medical staff – either as an extra burden or as a method of making everyday’s work easier. It has been shown that by combining telecommunications with telemedicine, the autonomy of users will grow which could prove a hard to accept situation by the medical professionals. The success of TeleMed will also be influenced by the way it is going to differentiate itself from present and future competitors. At the moment, the biggest competitor is Stayhealthy, which offers the so-called “health-kiosk”. Differentiating aspects in regards to the medical tests performed can be briefly mentioned – RFID skin patches, blood tests (performed by the finger-prick), lung tests alongside the advantage of placing TeleMed in Denmark – the Danish healthcare system (where patients do not have to pay for health care) is totally different than the e.g. American system. Reputation, security, acceptance by medical professionals and differentiating aspects are issues that can only be evaluated after deployment of TeleMed. At the moment, the financial and legislative aspects are of greater importance. After analyzing different costs directly related to TeleMed (with the focus on transaction costs) we have established as viable solution a cost of 7.470.000 DKK for a pilot study (for the detailed calculation, the reader is advised to read chapter 3.2.2) and we have identified potential investors e.g. Aalborg University. In regards to legislation, TeleMed is aimed at using existent legislation (taking advantage of work already done by projects like Telekat), without requiring new laws which could delay the deployment. The field of medicine, in general, is a field marked by continuous research and developments. In order to address this trend, TeleMed will benefit from a change management board whose first tasks will be analyzing incorporating developments like the blood chip and the iris tests (tests not accepted at the moment but still worth considering on a long-term situation). The overall conclusion is that the TeleMed innovators feel that this project could lead Denmark in a dominant position in the telemedicine field, given that a number of essential factors join forces towards a common goal - “Improving the general health in Denmark by the use of telecommunication technologies” 89 7.Bibliography Aladwani, A. M. (2001). Change management strategies for successful ERP implementation. 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American Journal of Sociology 87. 93 Acronyms AON - activity on node AOA - activities on arrow HIV - Human immunodeficiency virus EHR – Electronic Health record CAB - Change Advisory Board RFC - Request for Change IT – Information technologies E-Signature – Electronic signature ITIL - Information Technology Infrastructure Library SLM – Service Level Management ISO – International Organization of Standardization RM - Reference Model ODP - Open Distributed Processing UML – Unified Modeling Language XML – Extensible markup Language ICT – Information and Communication Technologies HTTPS – Hyper Text Transfer Protocol Secure HTTP – Hypertext Transfer Protocol TLS – Transport Layer Security CA – certificate authorities RA – Registration authorities PKI – Public Key Infrastructure OSI - Open System Interconnection Reference Model BMI – Body Mass Index RFID - Radio-Frequency Identification RESHEN – Regional Secure Healthcare Networks FVC – Forced Vital Capacity FEV – Forced Expiratory Volume FEF – Forced Expiratory Flow PEF – Peak Expiratory Flow MVV – Maximum Voluntary Ventilation SVC – Slow Vital Capacity TLC – Total Lung Capacity FRC – Functional Residual Capacity 94 ERV – Expiratory Reserve Volume COPD - Chronic obstructive pulmonary disease GOLD - Global Initiative for Obstructive Lung Disease VC – Vital Capacity UCLA – University of California, Los Angeles CD4 - cluster of differentiation 4 DNA - Deoxyribonucleic acid 95 8.Attachments Attachment 1: Questionnaire Beskrivelse af vores projekt: Vi er kandidatstuderende på Aalborg Universitet indenfor Innovativ Kommunikationsteknik og Entrepreneurship. Vi har udviklet en maskine der skal danne besparelser omkring sundhedssektorens infrastruktur samt forebygge sygdomme. Maskinen har udseende af en pengeautomat, men tilbyder i stedet at få testet sin krop samt indhente information. Maskinen tilbyder, at der bl.a. kan foretages test af blod (hvilket kan vise kolesteroltal og andre vigtige parametre), lunger kan blive analyseret, blodtryk kan undersøges samt andre parametre som kan give prej om ens sundhed. Information om kost, træning samt kontakt til læger kan også indhentes i maskinen. Maskinen står frit tilgængeligt i det offentlige og anvendelse kræver ingen kontakt med personale. Informationer fundet frem af maskinen kan videresendes til patientens læge, men der er også mulighed for en komplet anonym undersøgelse. Det er naturligvis gratis for borgerne at anvende maskinen. I udviklingen af denne maskine, er der en del brugerkriterier som vi vil være yderst taknemmelige hvis Du vil hjælpe os med at finde svar på. Personlige informationer: A: Deres køn? B: Deres alder? Lider De af en kronisk sygdom? (Marker med understregning) A: Nej B: Ja Hvis ja, hvilke(n):________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________ Lokalisering af maskinen: Vi vil bede Dem om at sætte disse lokaliteter i rækkefølge efter hvor De ville foretrække at anvende maskinen. 1 er Deres foretrukne sted, mens 3 er stedet De vil være mindst villig til at anvende maskinen: 1. 2. 3. Ved indgangen til et centralt liggende fitness center: Ved indgangen til en centralt liggende læge: (123) Ved indgangen til et hospital: (123) (123) Er der andre steder du ville foretrække:__________________________________ 96 Anvendelse af maskinen: Hvor ofte vil De formode at anvende maskinen? (Marker med understregning) A: Ugentligt B: Månedligt C: Hvert kvartal D: Halv-årligt E: Årligt F: Sjældnere G: Aldrig Hvad vil De formode at anvende maskinen til? (Marker med understregning, vælg gerne flere) A: Blodprøver B: Test af lunger C: Højde/vægt D: Indhente information om næring og træning E: Læse om symptomer på sygdomme F: Booke tid hos egen praktiserende læge Troskab i teknologi: Hvor stor tiltro har De til at lade en maskine vurdere Deres helbredsmæssige tilstand? (Marker med understregning) 1: Meget 2: En del 3: Middelmåddigt 4: Ringe tiltro 5: Ingen tiltro Deres normale lægebesøg: Hvor ofte tager De henvendelse til deres praktiserende læge? (Marker med understregning) A: Ugentligt B: Månedligt C: Halv årligt D: Årligt E: Sjældnere Yderligere kommentarer: Hvis De har yderligere kommentarer til denne maskine som De gerne vil dele, vil vi være taknemmelige: Tak fordi de fandt tid til at besvare spørgsmålene 97 Attachment 2: Venture Cup leaflet Introduction: Telemedicine is a well-known concept but yet not being used to its fullest on the Danish market. As it is, only basic telemedicine equipment is being used even though hospital scientists are welcoming a more extended use of telemedicine as seen in e.g. United Kingdom. TeleMed is offering the Danish society free use of a range of telemedicine components as well as introducing a new innovative infrastructure not yet seen on the world market, as well as the incorporation of new futuristic medical treatments. Team: We are three students of different nationality currently enrolled as master students at Aalborg University on the Innovative Communication Technologies and Entrepreneurship (ICTE) course at the Center for Communication, Media and Information Technologies (CMI). Andrei Lucian Stefan (09.11.1986) Holds an engineering BsC in Telecommunications achieved at Faculty of Electronics, Telecommunications and Information Technology at Bucharest University, Romania. At the faculty Andrei was employed as an assistant teaching seminars and performing lab assignments for students at third-year-level. Overall his main experienced is concentrated around networking. At Aalborg University he is employed at the CTIF Easy Life Lab as Student Helper working on a specific 3D localization project in the RFID field. Andrei holds a Cisco certificate – CCNA. Claus Ladefoged (18.09.1985) Holds a BsC in Library and Information Science from Royal School of Library and Information Science, Aalborg. The last two semesters of this degree Claus was accepted to join the Information Studies course at Faculty of Computer and Information Studies at Sheffield University, England. Claus holds honors for his academic achievements by scholarships. Overall his experience is within information retrieval, information systems and Internet technologies. Former working experience counts consultancies work performing statistics in own company. Juras Klimasauskas (11.06.1985) Holds an engineering BsC in Informatics at Siauliai University at Faculty of Technologies, Lithuania. Afterwards Juras took one year of master studies in Management and Business Administration at Faculty of Economics and Finance Management at Mykolas Romeris University, Lithuania. Also, he completed one Erasmus semester at Faculty of Computer Engineering at Yildiz Technical University, Turkey. Juras’ main experience is within computer/database systems, informatics engineering, software systems and electronic services. 98 This group has been established since we have three different backgrounds and on a wide scientific field as telemedicine, where a variety of knowledge is needed, we are able to contribute with our personal knowledge. We hereby learn from each other but also broaden our possibilities. What is telemedicine? The term telemedicine covers medical treatment outside ordinary locations like hospitals, doctors etc. E.g. on telemedicine is an isolated doctor in rural areas of Africa obtaining information on how to perform a surgery via Internet or elderly people performing blood pressure test in their private homes. Overall, telemedicine is bringing medical treatment to other suitable locations. The project objectives: Our TeleMed project is a semester-project with the option of continuing the work process in later semesters. The tasks given at the beginning of the semester was simply to introduce something innovative within the telemedicine sphere and as so the objectives are not predefined but forces the group to implement innovation and become knowledgeable with entrepreneur skills. Innovation: The innovation offered with the TeleMed project contains both product and service innovation. As a starting point the product is designed for the Danish market while Denmark is lacking behind in the telemedicine field (though funding and interest is available) and the Danish citizen is ready for a product as technical reliant as TeleMed (questionnaires have been made to clarify the publics intentions of usage and to gain ideas). The most basic product innovation is gathering a variety of telemedicine components into one single machine. The machine has the look of an ATM-machine but offers the client to perform various health care check-ups such as measuring blood pressure, pulse, eye-test, weight/height, temperature, lungs, oxygen saturation and offers information on nutrition, symptoms and training programs. So far telemedicine components measuring these data exists but has only once been incorporated into one machine (StayHealthy Health Kiosk from USA), while our machine offers a wider variety of tests and new possibilities of being tested – in more efficient ways. First major differentiation is an RFID-patch. The patch is simply collected at the machine, being placed on the client’s body for however long the client wants to be tested. Afterwards the client returns to the machine and a reader collects data from the RFID showing statistics on the machine regarding the client’s blood pressure, temperature and more having the benefit of showing highly approved information. A second major differentiation is the usage of finger prick tests. This enables possibilities of showing indications on a large variety of RFID-tag diseases. So far hygiene has been the only obstacles preventing finger prick tests to be performed, but with our new service innovation, the solution has been found: The TeleMed project features infrastructural changes in the medical sector. The machine in freely available for the public at pin-pointed doctor offices making it possible having assistants making sure hygiene is in order, and making it legal to perform finger prick tests penetrating skin. Placing this universal machine free-of-charge at the doctor’s office will prevent diseases and give new possibilities never achieved before. Another innovative idea within the main idea is a database system making it possible, if approved by the client, for the doctor to obtain information on the patient gathered in the machine. This 99 makes it easier for the doctor to suggest a diagnose having data to base decision upon, and not only in-the-moment information based on test doing an ordinary doctor appointment. Other future prospects of possible implementations to the TeleMed machine are listed in confidential documents, but overall TeleMed seeks to be in front of technological advantages. Having questioned the public, it became clear that many people avoid regular ordinary doctor meetings, while the anonymous test with TeleMed would be preferable and that the public would be interested in using the advantages of TeleMed as prevention and frequent check-up. For problem solving and facing obstacles before launching the product thorough research of legislation and cooperation with relevant lawyers has been produced, and currently no Danish laws are against implementing TeleMed to the market. Market Having searched the telemedicine market, it became clear that especially the need of telemedical options for diabetes, lung and heart diseases are matters with severe problems – and we believe our idea prevents/helps all of these diseases. TeleMed has a clear business model and a final calculation of a pilot study costing 7.470.000 dkr. This number arrives from calculation of wages, final development of software and the distributor of telemedicine components being the company A&D. A market research has been produced stating the big opportunities of our project to work. The pilot study can be financed by private companies (as seen with other Danish telemedicine projects, like TELEKAT) while final launching and maintenance is a governmental issue (the state being interested to invest due to savings on less sick people because of the prevention). In this sense, TeleMed is not a project to earn money, but to save money. The main idea surrounding A&D component TeleMed can be launched at other national markets, but will find hurdles in e.g. for blood USA with insurance companies. pressure tests Already now, after only three months progress in the project, Tunstall Healthcare has shown interest in being possible investors. Especially in a specific designed edition of the machine made for nursery homes – another open market for telemedicine. Summary In the research/development process the team has used a variety of sources to make sure the idea is possible and to make sure the need of the machine is alive. By questionnaires, interviews (with lawyers, blood specialists, lunge specialists, telemedicine professors, doctors, competitors, distributors, supervisors etc) and getting to know the electronic components, we are confident that the TeleMed machine can show a success. Denmark, at first, can show major improvements in preventing diseases and by the end of the day safe capital on hospital beds. 100