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研究生:劉家華
研究生(外文):LIU, CHIA-HUA
論文名稱:基於區塊鏈強化醫療電子產品設計流程可信度
論文名稱(外文):Strengthening Medical Product Design Process with Trustworthiness Based on Blockchain
指導教授:莊東穎莊東穎引用關係曾俊元曹偉駿曹偉駿引用關係
指導教授(外文):Juang, Tong-YingTseng, Chin-yangTsaur, Woei-Jiunn
口試委員:游坤明莊東穎曾俊元曹偉駿
口試委員(外文):Yu, Kun-MingJuang, Tong-YingTseng, Chin-yangTsaur, Woei-Jiunn
口試日期:2020-07-28
學位類別:碩士
校院名稱:國立臺北大學
系所名稱:多媒體與網路科技產業碩士專班
學門:電算機學門
學類:網路學類
論文種類:學術論文
論文出版年:2020
畢業學年度:108
語文別:中文
論文頁數:46
中文關鍵詞:ISO 13485區塊鏈醫療電子資訊安全
外文關鍵詞:ISO 13485BlockchainMedical ElectronicsInformation Security
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現今醫療電子開發過程中,對於產品品質與檢驗之要求,均比一般商用電子類產品來的重要與嚴格。有鑒於目前醫療器材開發流程皆依據ISO 13485 醫療器材品質管理系統之標準流程執行,此品質管理系統提供一個明確的標準程序,作為醫療產品開發與驗證的統一標準。但ISO 13485醫療器材品質管理流程之設計驗證階段與試產驗證階段所產出之設計文件資料皆採紙本及電子檔之方式呈現,並無法杜絕為符合醫療器材上市規範之審查,而竄改原始產品設計文件之行為。
本研究目的為運用區塊鏈技術中的智能合約作為提高醫療電子產品設計流程可信度之重要工具,包含兩階段:第一階段為「產品設計驗證與儲存階段」,將設計文件透過雜湊函數產生雜湊值放入區塊鏈中,並加密設計文件後,儲存至資料中心,以提升設計文件之完整性與機密性;第二階段為「資料驗證與取得階段」,運用智能合約的「自動化」、「快速化」等功能特性來正確取得設計文件,以達到資料的可信度,故將有效杜絕偽造或竄改等人為錯誤,進而提高醫療電子產品設計流程可信度,更能有效率且安全地存儲與取得醫療器材品質管理系統流程所產出之設計文件。

In the development of medical electronics today, the requirements for product quality and inspection are more important and stricter than those of general commercial electronic products. In view of the fact that the current medical device development process is performed according to the standard process of the ISO 13485 medical device quality management system, this quality management system provides a clear standard procedure as a unified standard for medical product development and verification. However, the design documents and data produced in the design verification and pilot run validation stages of the ISO 13485 medical device quality management process are presented in paper and electronic files, and it is impossible to prevent the review of compliance with the medical device listing specifications and tampering with the original product design documents.
The purpose of this research is to use smart contracts in blockchain technology as an important tool to improve the credibility of the design process of medical electronic products. It includes two stages: The first stage is the "product design verification and storage stage", which passes the design documents through a hash function Generate the hash value and put it into the blockchain, and encrypt the design document, and store it in the data center to improve the integrity and confidentiality of the design document; The second stage is the "data verification and acquisition stage", using the "Automation of smart contracts", "Quick" and other functional features to obtain design documents correctly to achieve the credibility of the data, so it will effectively prevent forgery or tampering and other human errors, thereby improving the credibility of the medical electronic product design process, efficient Safely store and obtain design documents produced by the medical device quality management system process.

第一章 緒論 1
1.1 研究背景 1
1.2 研究動機 4
1.3 研究目的 5
1.4 論文架構 6
第二章 文獻探討 8
2.1 醫療電子產品設計流程 8
2.2 區塊鏈技術於醫療產業之應用 14
2.3 區塊鏈合約技術探討 15
2.3.1 Ethereum 之原理及技術 15
2.3.2 智能合約 17
第三章 基於區塊鏈之醫療電子產品設計流程建構 19
3.1 系統架構 19
3.2 強化醫療產品設計流程 22
3.2.1 產品設計驗證與儲存階段 24
3.2.2 資料驗證與取得階段 25
3.3 智能合約演算法設計 27
3.3.1 產品設計驗證與儲存階段 27
3.3.2 資料驗證與取得階段 29
第四章 實作與評估 31
4.1 安全性分析 31
4.2 系統實作 32
4.2.1 產品設計驗證與儲存階段實作 34
4.2.2 資料驗證與取得階段實作 37
4.3 結果評估與比較 40
第五章 結論 42
參考文獻 43
著作權聲明 46

[1] 2018 Medical Devices Industry Yearbook, URL: http://www.itis.org.tw/book/download_sample.aspx?type=itispubfile&pubid=56898047, Accessed March 2020.
[2] MEDICAL DEVICE CONTRACT MANUFACTURING MARKET, URL: https://www.marketsandmarkets.com/Market-Reports/medical-device-contract-manufacturing-market-170622851.html, Accessed March 2020.
[3] The dynamics and future development of the global medical equipment industry, URL: https://www.twse.com.tw/ch/products/publication/download/0001000771.pdf,
Accessed March 2020.
[4] ISO 13485:2016(en) Medical devices Quality management systems Requirements for regulatory purposes, URL: https://www.iso.org/standard/59752.html, Accessed April 2020.
[5] ISO 9001:2008, Quality management systems Requirements, URL: https://www.iso.org/standard/46486.html, Accessed April 2020.
[6] My Health - My Data | MH-MD Project | H2020 | CORDIS | European Commission, URL: https://cordis.europa.eu/project/id/732907, Accessed May 2020.
[7] EMR – Clinfowiki, URL: https://www.clinfowiki.org/wiki/index.php/EMR, Accessed May 2020.
[8] V. Malamas, et al., “A Forensics-by-Design Management Framework for Medical Devices Based on Blockchain,” Proceedings of the 2019 IEEE World Congress on Services, Milan, Italy, pp. 35-40, 2019.
[9] R. Kumar and R. Tripathi, “Traceability of counterfeit medicine supply chain through Blockchain,” 2019 11th International Conference on Communication Systems & Networks, Bengaluru, India, pp. 568-570, 2019.
[10] X. He, S. Alqahtani and R. Gamble, “Toward Privacy-Assured Health Insurance Claims,” 2018 IEEE International Conference on Internet of Things (iThings) and IEEE Green Computing and Communications (GreenCom) and IEEE Cyber, Physical and Social Computing (CPSCom) and IEEE Smart Data (SmartData), Halifax,NS,Canada, pp.1634-1641, 2018.
[11] Gavin Wood, “Ethereum: A secure decentralised generalised transaction ledger,” Ethereum project yellow paper, pp. 1-34, 2014.
[12] Vitalik Buterin, URL: https://en.wikipedia.org/wiki/Vitalik_Buterin, Accessed May 2020.
[13] Sara Rouhani and Ralph Deters, “Security, performance, and applications of smart contracts: A systematic survey,” IEEE Access, pp. 50759-50779, 2019.
[14] A. Hrga, F. Benčić and I. P. Žarko, “Technical Analysis of an Initial Coin Offering,” 2019 15th International Conference on Telecommunications (ConTEL), Graz, Austria, pp. 1-8,2019.
[15] F. Vogelsteller and V. Buterin, "ERC-20 Token Standard", URL: https://eips.ethereum.org/EIPS/eip-20, Accessed May 2020.
[16] R. Taş and Ö. Ö. Tanrıöver, “Building A Decentralized Application on the Ethereum Blockchain,” 2019 3rd International Symposium on Multidisciplinary Studies and Innovative Technologies (ISMSIT), Ankara, Turkey, pp. 1-4, 2019.
[17] N. Szabo, "Smart Contracts: Building Blocks for Digital Markets", URL: http://www.fon.hum.uva.nl, Accessed May 2020.
[18] J. Riedl, “Crowdfunding Technology Innovation,” Computer, pp. 100-103, March 2013.

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