臺灣博碩士論文加值系統

醫療器材一般用於提供病人進行醫療行為或提供醫療資訊，若其產生失效，將對病人或使用者造成危害。本研究以開發一遠距健康照護系統結合臺大醫院提供的醫療服務為例，導入美國食品藥物管理局（Food and Drug Administration, FDA）於醫療器材開發確效通用準則，依循其認證所需進行開發作業程序，包含需求發展、技術解決方案、驗證、確效、上市前呈遞資料、及法規管理等領域，以改善傳統繁瑣的開發流程。
本遠距照護系統的設計理念是結合商用醫療器材（血氧機、血糖機、血壓機與心電圖機）透過其藍牙通信無線傳輸量測資料至Android 行動裝置，亦與藍芽之醫療裝置協定（Health Device Profile, HDP）整合實現Intel ContinuaR醫療聯盟之通訊規範可容性。得以減少實體線路的空間及整合多樣感測設備，使量測環境不受限制，再將所量測的數據及GPS定位資訊通過隨身網路傳送至臺大醫院遠距照護中心的醫療雲端中儲存匯整，以達到即時監測及發送信息或警報等應用，得以幫助長期照護使用者的健康狀況。本系統已完成臺大醫院的臨床試用性評估，基於臨床測試者的使用者經驗回饋，在系統優化、流暢度都更貼近使用需求，友善直覺式的操作將大幅提升大眾的使用意願。
本系統亦可協助判讀量測誤差，經演算法處理後將人為操作所造成的失效量測資料回報給使用者，請求再次量測，如此不但可增進量測效率也可減少個案管理師工作量。基於個人隱私及安全性的考量，我們亦實現符合高級加密標準（Advanced Encryption Standard, AES）之心電圖量測設備。

Medical devices, which used to be designed by users with medical background, such as doctors, technicians, and other medical staff, have become insufficient for today’s needs because of there are more and more non-medical background users.
Design methods regulated by United States Food and Drug Administration (FDA) offers a refined solution for the problems in medical device design, as they do in many other medicine fields. In this study, applying these methods to the medical device design process, especially in telehealth system design, is going to be examined.
In this thesis, we propose a digital mobile healthcare system, which integrates wearable sensors, smart phone, and National Taiwan University Hospital (NTUH) telehealth center, to facilitate the management of point-of-care. The system utilizes wireless connection between wearable sensors and mobile devices with Bluetooth interface to automatically collect physiological signal, such as blood oxygen saturation, blood glucose, blood pressure, and electrocardiography (ECG). It allows users, especially seniors with chronic diseases, to conveniently record daily measurement results and track long term health condition changes regardless of their locations.
For interoperability consideration, we design our system as a ContinuaR- compatible manager. We also perform clinical trial in NTUH to validate our system usability.
FDA regulatory decision and security issue are also discussed in the thesis.

Chinese Abstract I
English Abstract III
List of Contents V
Index of Figures VIII
Index of Tables XI

Chapter 1 Overview 1
1.1 Introduction 1
1.2 Motivation 2
1.3 Road Map 2

Chapter 2 Medical Device Design Process 5
2.1 Innovation and Medical Device Development 5
2.2 General Specification of Medical Device Design 8
2.3 Design Process of Digital Mobile Healthcare System 10

Chapter 3 Discovery and Ideation 12
3.1 User Need of Health Monitoring System 12
3.1.1 Common architectures for Health Monitoring System 12
3.1.2 Mobile Architecture for Telecare Management 15
3.2 Existing Telehealth Systems in Taiwan 16
3.2.1 National Taiwan University Hospital – Telecare Center 16
3.2.2 Changhua Christian Hospital –
Bariatric Surgery and Diabetes Health Management Center 18
3.3 Patent Survey 18
3.4 Summary 20

Chapter 4 Invention and Prototyping 22
4.1 Design Input 22
4.1.1 Wearable Sensors 23
4.1.2 Smartphone 23
4.1.3 Web Service 24
4.1.4 NTUH Telehealth Center 24
4.2 Design Process 25
4.2.1 Android Development Platform 25
4.2.2 KSOAP2 27
4.2.3 AChartEngine 27
4.2.4 Software framework 27
4.2.5 GUI Module 28
4.2.6 Interface Module 29
4.2.7 Notification Module 29
4.3 Design Output 29
4.3.1 Automation Search-Connect Service 31
4.3.2 ECG Analyzing Service 31
4.3.3 Integration with GPS and Google Map 32

Chapter 5 Pre-Clinical and Clinical 35
5.1 Verification 35
5.1.1 Precondition 35
5.1.1 ContinuaR Design Guidelines 36
5.1.2 Interoperability Tests and Evaluation 39
5.2 Validation 41
5.2.1 Heuristic Evaluation 41
5.2.2 Clinical Trial Results 42
5.2.3 Discussion 44

Chapter 6 Regulatory Decision 46
6.1 FDA Regulatory Process 47
6.1.1 Medical Device Classification 47
6.1.2 Premarket Notification (510(k)) Clearance 50
6.2 Security Issue 54
6.2.1 Advanced Encryption Standard 55
6.2.2 AES Based ECG SoC 55
6.2.3 Hardware Implementation 56
6.2.4 Simulation Result 57
6.3 Conclusion and Comparison 58

Reference 62

[1]International Telecommunication Union http://www.itu.int/en/ITU-D/Statistics/Documents/facts/ICTFactsFigures2013.pdf. Accessed June 28, 2013.

[2]Victor Shnayder, Borrong Chen, Konrad Lorincz, Thaddeus R. F. FulfordJones, and Matt Welsh, Sensor Networks for Medical Care, Technical Report TR-08-05, Division of Engineering and Applied Sciences, Harvard University, 2005.

[3]Georgios Kambourakis, Eleni Klaoudatou and Stefanos Gritzalis, Securing Medical Sensor Environments: The CodeBlue Framework Case, Second International Conference on Availability, Reliability and Security, pp. 637-643 (ARES''07).

[4]Babybot, http://babybot.com/, Accessed June 20, 2013.

[5]DigiO2, http://www.digio2.com/, Accessed June 20, 2013.

[6]Tia Gao, Dan Greenspan, Matt Welsh, Radford R. Juang and Alex Alm, Vital Signs Monitoring and Patient Tracking Over a Wireless Network, In Proceedings of the 27th Annual International Conference of the IEEE EMBS, pp. 102-105, Conference on September 2005.

[7]Subhas C. Mukhopadhyay*, Anuroop Gaddam and Gourab S. Gupta, Wireless Sensorsfor Home Monitoring - A Review, 2008 Bentham Science Publishers Ltd and Recent Patents on Electrical Engineering, pp. 32-39, 2008.

[8]Going Mobile with a Multiaccess Service for the Management of Diabetic Patients,Giordano Lanzola, Davide Capozzi, Giuseppe D’Annunzio, Pietro Ferrari, Riccardo Bellazziand Cristiana Larizza, Journal of Diabetes Science and Technology, Volume 1, Issue 5,September 2007.

[9]Peter Leijdekkers, Valerie Gay and Edward Barin, Trial Results of a Novel CardiacRhythm Management System Using Smart Phones and Wireless ECG Sensors. ICOST 2009, LNCS 5597, pp. 32–39, 2009.

[10]W. Chung, et al., A Cell Phone Based Health Monitoring System with Self Analysis Processor using Wireless Sensor Network Technology (29th EMBC), pp. 3705-3708, 2007.
[11] Hsin-Lu Chang, Michael J Shaw, Feipei Lai, Wen-Je Ko, Yi-Lwun Ho, Heng-Shuen Chen and Chin-Chung Shu, “U-Health: an example of a high-quality individualized healthcare service, “ Personalized Medicine, Vol. 7, No. 6, pp. 677-687, Nov. 2010.

[12]Pei Hsuan Wu, Chi-Huang Chen, Huai-Te Chen, Che-Hsuan Shu, Feng-Sheng Lin, Yi-Van Wang, Hao-Jhun Li, Yuan-Ting Wu, Feipei Lai, “User Inspection of National Taiwan University''s Telehealth Care System,” 32nd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, August 31 - September 4, 2010, Buenos Aires, Argentina

[13]Bariatric Surgery and Diabetes Health Management Center at Changhua Christian Hospital, http://www2.cch.org.tw/cch_english/news_detail.aspx?id=56, Accessed July 1, 2013.

[14]Android developer, http://developer.android.com/intl/es/sdk/index.html, Accessed July 1, 2013.

[15]KSOPA2-ANDROID, http://code.google.com/p/ksoap2-android/, Accessed June 20, 2013.

[16]KSOPA2-ANDROID,http://ksoap2.sourceforge.net/, Accessed June 20, 2013.

[17]Achartengine, http://code.google.com/p/achartengine/, Accessed June 20, 2013.

[18]Android-Bluetooth, http://code.google.com/p/android-bluetooth/, Accessed June 20, 2013.

[19]Lesh, K.; Weininger, S.; Goldman, J. M.; Wilson, B. & Himes, G.(2007), Medical Device Interoperability-Assessing the Environment, in Proceedings of the 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability'', IEEE Computer Society, Washington, DC, USA, pp. 3-12.

[20]The Institute of Electrical and Electronics Engineers, Inc. (2008), ''Health Informatics-Personal Health Device Communication Part 20601: Application Profile- Optimized Exchange Protocol'', IEEE STD 11073-20601-2008, 1 -198.

[21]Nielsen, J. (2006). 10 Heuristics for User Interface Design, http://www.useit.com/papers/heuristic/heuristic_list.html Accessed June 20, 2013.

[22]U.S. Food and Drug Administration 510(k) Premarket Notification https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm, Accessed July 8, 2013.

[23]J. Daemon and V. Rijman, “AES Proposal: Rijndael”, http://csrc.nist.gov/CryptoToolkit/aes/rijndael/Rijndael-ammended.pdf

[24]National Institute of Standards and Technology (NIST), AES Test Vectors, http://csrc.nist.gov/CryptoToolkit/aes/rijndael/rijndael-vals.zip.