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題名 論智慧醫療時代下健康資料之商業應用─個人資料保護與競爭法之交錯
Commercial Use of Health Data in the age of eHealth: The Intersection of Personal Data Protection and Competition Law作者 楊惟珽
Yang, Wei-Ting貢獻者 鄭菀瓊
Cheng, Wan-Chiung
楊惟珽
Yang, Wei-Ting關鍵詞 健康資料
個人資料保護法
競爭法
公平交易法
隱私權
大數據
智慧醫療
Health Data
Data Privacy
Competition Law
Antitrust Law
Big data
eHealth日期 2024 上傳時間 4-九月-2024 13:59:41 (UTC+8) 摘要 在智慧醫療發展下，創新研發有賴於健康資料的蒐集與分析，數據驅動的併購規模亦更勝以往，惟同時也引發個人資料保護與市場競爭之問題。目前文獻上多有討論大數據應用下的個人資料保護爭議，或有關網路平台的競爭法議題，惟以健康資料為核心者仍為少數。本文比較美國、歐盟與臺灣健康資料保護法規之異同，並分析美國與歐盟相關文獻及與隱私保護相關之競爭法案例，以作為探討在醫療保健領域競爭法與個人資料保護法之間如何互動之基礎。本文認為，面對同時存在的資料保護問題與競爭問題兩種市場失靈，競爭法中有考量隱私問題之必要。企業制定的隱私權政策或有構成濫用市場支配地位之可能；而涉及健康資料的結合審查，應考量健康資料的敏感性、可近性及資料聚合之效果。
With the development of eHealth, innovative research and development relies on the collection and analysis of health data. The scale of data-driven mergers and acquisitions has also surpassed previous levels. This trend, however, also raises concerns regarding personal data protection and market competition. While existing literature has extensively discussed personal data protection issues in the context of big data and the competition law issues related to online platforms, there was little focus on health data. This study compared the regulatory frameworks for health data protection in the United States, the European Union, and Taiwan, and analyzed relevant literature and competition law cases related to privacy protection in the U.S. and the EU. The findings provided a basis for exploring the interplay between competition law and personal data protection law in healthcare industry. This study argues that, in addressing the dual market failures of data protection and competition issues, it is necessary to consider privacy concerns in competition law. 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國立政治大學
科技管理與智慧財產研究所
110364213資料來源 http://thesis.lib.nccu.edu.tw/record/#G0110364213 資料類型 thesis dc.contributor.advisor 鄭菀瓊 zh_TW dc.contributor.advisor Cheng, Wan-Chiung en_US dc.contributor.author (作者) 楊惟珽 zh_TW dc.contributor.author (作者) Yang, Wei-Ting en_US dc.creator (作者) 楊惟珽 zh_TW dc.creator (作者) Yang, Wei-Ting en_US dc.date (日期) 2024 en_US dc.date.accessioned 4-九月-2024 13:59:41 (UTC+8) - dc.date.available 4-九月-2024 13:59:41 (UTC+8) - dc.date.issued (上傳時間) 4-九月-2024 13:59:41 (UTC+8) - dc.identifier (其他 識別碼) G0110364213 en_US dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/153132 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 科技管理與智慧財產研究所 zh_TW dc.description (描述) 110364213 zh_TW dc.description.abstract (摘要) 在智慧醫療發展下，創新研發有賴於健康資料的蒐集與分析，數據驅動的併購規模亦更勝以往，惟同時也引發個人資料保護與市場競爭之問題。目前文獻上多有討論大數據應用下的個人資料保護爭議，或有關網路平台的競爭法議題，惟以健康資料為核心者仍為少數。本文比較美國、歐盟與臺灣健康資料保護法規之異同，並分析美國與歐盟相關文獻及與隱私保護相關之競爭法案例，以作為探討在醫療保健領域競爭法與個人資料保護法之間如何互動之基礎。本文認為，面對同時存在的資料保護問題與競爭問題兩種市場失靈，競爭法中有考量隱私問題之必要。企業制定的隱私權政策或有構成濫用市場支配地位之可能；而涉及健康資料的結合審查，應考量健康資料的敏感性、可近性及資料聚合之效果。 zh_TW dc.description.abstract (摘要) With the development of eHealth, innovative research and development relies on the collection and analysis of health data. The scale of data-driven mergers and acquisitions has also surpassed previous levels. This trend, however, also raises concerns regarding personal data protection and market competition. While existing literature has extensively discussed personal data protection issues in the context of big data and the competition law issues related to online platforms, there was little focus on health data. This study compared the regulatory frameworks for health data protection in the United States, the European Union, and Taiwan, and analyzed relevant literature and competition law cases related to privacy protection in the U.S. and the EU. The findings provided a basis for exploring the interplay between competition law and personal data protection law in healthcare industry. This study argues that, in addressing the dual market failures of data protection and competition issues, it is necessary to consider privacy concerns in competition law. Corporate privacy policies may constitute an abuse of market dominance, and merger reviews involving health data should account for the sensitivity, accessibility, and aggregation effects of such data. en_US dc.description.tableofcontents 第一章 緒論 1 第一節 研究動機與目的 1 第二節 研究方法與範圍 4 第三節 論文架構 5 第二章 健康資料與醫療大數據 7 第一節 健康資料概述 7 第一項 健康資料之定義 7 第二項 健康資料之類型 11 第三項 健康資料之取得 13 第二節 醫療大數據之商業應用 20 第一項 醫療大數據 20 第二項 醫療大數據之商業應用 22 第三節 小結 26 第三章 各國健康資料保護規範 27 第一節 臺灣 27 第一項 個人資料保護法 28 第二節 歐盟 33 第一項 個人資料保護規則 33 第二項 歐洲健康資料空間規則草案 41 第三節 美國 46 第一項 健康保險可攜性與責任法（HIPAA） 47 第二項 經濟和臨床健康之健康資訊科技法（HITECH） 55 第三項 加州消費者隱私保護法（CCPA）與加州隱私權法（CPRA） 56 第四節 各國資料保護法規比較 61 第一項 賦予資料主體的權利 61 第二項 課予資料持有者之義務 63 第五節 現行健康資料保護法規未竟之問題 64 第一項 資料蒐集 64 第二項 資料處理 66 第三項 資料散播 68 第四項 決策干預 70 第六節 小結 74 第四章 健康資料之商業應用與競爭法 76 第一節 競爭法與個人資料保護 77 第二節 大數據發展下可能的競爭態樣 82 第一項 獨占地位濫用 82 第二項 結合行為 85 第三項 聯合行為 87 第三節 相關市場界定 90 第一項 相關市場界定之困難 90 第二項 適用於數據之相關市場界定方法 94 第四節 與健康資料相關之競爭法案例 97 第一項 拒絕授權：IMS Health v. NDC Health 97 第二項 併購 101 第三項 資料濫用：Flo Health, INC. 110 第五節 小結 114 第五章 以競爭法完善健康資料保護制度 116 第一節 隱私風險應納入競爭法之考量 116 第一項 市場失靈難以自我矯正 116 第二項 消費者福利概念與競爭分析 118 第二節 隱私權政策方面 120 第三節 結合案件方面 125 第一項 結合審查 125 第二項 結合補救措施 130 第四節 競爭法與資料可攜權 132 第五節 小結 135 第六章 結論 136 參考文獻 138 zh_TW dc.format.extent 4307294 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0110364213 en_US dc.subject (關鍵詞) 健康資料 zh_TW dc.subject (關鍵詞) 個人資料保護法 zh_TW dc.subject (關鍵詞) 競爭法 zh_TW dc.subject (關鍵詞) 公平交易法 zh_TW dc.subject (關鍵詞) 隱私權 zh_TW dc.subject (關鍵詞) 大數據 zh_TW dc.subject (關鍵詞) 智慧醫療 zh_TW dc.subject (關鍵詞) Health Data en_US dc.subject (關鍵詞) Data Privacy en_US dc.subject (關鍵詞) Competition Law en_US dc.subject (關鍵詞) Antitrust Law en_US dc.subject (關鍵詞) Big data en_US dc.subject (關鍵詞) eHealth en_US dc.title (題名) 論智慧醫療時代下健康資料之商業應用─個人資料保護與競爭法之交錯 zh_TW dc.title (題名) Commercial Use of Health Data in the age of eHealth: The Intersection of Personal Data Protection and Competition Law en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 一、中文資料 （一）書籍 楊智傑（2024），個人資料保護法論，二版，台北：元照出版。 （二）專書論文 陳志民（2009），消費者福利、消費者保護、及競爭政策，收於：公平交易委員會編，第 16 屆競爭政策與公平交易法學術研討會論文集，頁227-260。 陳志民、陳和全（2011），結合矯正措施之研究，收於：公平交易委員會編，第 18 屆競爭政策與公平交易法學術研討會論文集，頁179-235。 郭戎晉（2022），競爭法與隱私法之界線暨判斷標準之研究，收於：公平交易委員會編，第28屆競爭政策與公平交易法學術研討會論文集，頁71-104。 （三）期刊論文 宋皇志（2020），大數據之競爭法議題──以限制競爭為中心，政大法學評論，第163期，頁49-138。 李伯璋（2020），健保資料人工智慧應用與展望，台灣經濟論衡，18卷4期，頁22-29。 李孟芬、潘立傑（2012），淺談行動健康服務的應用，長期照護雜誌，16卷3期，頁237-250。 李宛諭（2021），大數據與競爭法，公平交易季刊第29卷第4期，頁123-180。 林克亮、楊子芃、林世傑、賴妍倩、陳純子、李英雄（2017），精準醫療未來發展之大趨勢，台灣醫檢雜誌，32卷4期，頁25-37。 翁清坤（2013），告知後同意與消費者個人資料之保護，臺北大學法學論叢，第 87 期，頁217-322。 翁清坤（2016），網路上隱私權政策之效力：以美國法為中心，臺大法學論叢，45卷1期，頁151-248。 高翊瑋、侯藹玲、葉玲瓏、姜葉飛（2016），醫療大數據概述，數據分析，11 卷 5 期，頁 1-11。 張志偉（2018），歐盟資料保護基本規則導論，月旦司律評，創刊號，頁 164-172。 張媛筑（2018），競爭法上使用者數據之應有定位與可能造成之衝擊，公平交易季刊，第26卷第4期，頁125-164。 許佑寧（2019），德國聯邦卡特爾局限制 Facebook 蒐集整併不同來源的用戶數據以防壟斷，科技法律透析，31 卷 5 期，頁2-4。 許明暉（2020），精準醫療年代的健康資料治理，國土及公共治理季刊，8卷3期，頁76-81。 陳志民（2018），大數據與市場力濫用行為初探，公平交易季刊，第26卷第3期，頁1-33。 程法彰（2022），競爭秩序下的消費者保護在數位經濟的大數據時代中個人資料保護的角色，高大法學論叢，第18卷第1期，頁129-174。 楊宏暉（2023），從德國 Facebook 案談競爭與隱私之交匯，公平交易季刊，31卷1期，頁1-66。 劉孔中（2007），以關鍵設施理論限制專利強制授權之範圍，公平交易季刊，15卷1期，頁25-58。 劉定基（2009），欺罔與不公平資訊行為之規範-以美國聯邦交易委員會的管制案例為中心，公平交易季刊，17卷4期，頁57-91。 顏雅倫（2016），雙邊／多邊市場之競爭與創新－論競爭法的因應，科技法學評論， 13 卷 1 期，頁219-266。 （四）研討會論文 紀振清（2004），基礎設備理論於醫療事業之適用與探討，第七屆競爭政策與公平交易法學術研討會，公平交易委員會主辦。 （五）學位論文 邱映曦（2019），競爭法的數位紀元－論數位平台資訊力對競爭法適用之影響，國立政治大學法律學系博士論文（未出版），臺北。 謝存恩（2022），資料可攜規範之研究-以巨型線上平台為中心，國立臺灣大學法律學院法律學研究所碩士論文（未出版），臺北。 （六）官方文件與機構報告 公平交易委員會（2023），數位經濟與競爭政策白皮書。 王明禮主持（2021），數位市場與結合管制，公平交易委員會委託研究報告。 吳秀明主持（2020），公平交易法國內重要案例之評析-以欺罔或顯失公平行為為例，公平交易委員會委託研究報告。 （七）網路資料 中央研究院生物醫學科學研究所，台灣精準醫療計畫，載於: https://tpmi.ibms.sinica.edu.tw/www/。 財團法人資訊工業策進會，生醫健康資料商化應用平台，載於：https://healthdata.iii.org.tw/index.html。 李伯鋒（2022），Amazon 併購 One Medical，擴展醫療事業，外界憂慮醫療數據不當使用，關鍵評論網媒體集團，載於：https://www.inside.com.tw/article/28355-amazon-buys-one-medical. 徐曼慈（2019），德國聯邦卡特爾署決定禁止Facebook濫用市場力不當處理用戶資料之行為，公平交易委員會電子報，122 期。 國家衛生研究院，全民健康保險研究資料庫內容說明，載於：https://nhird.nhri.edu.tw/news。 許佳琦（2022），月經紀錄app成為「墮胎罪證」？羅訴韋德案推翻後的女性恐懼，轉角國際，載於：https://global.udn.com/global_vision/story/8664/6458320。 陳昱婷（2023），iRent個資外洩40萬筆 北市開罰最高額9萬元，中央通訊社，載於：https://www.cna.com.tw/news/ahel/202302090311.aspx。 黃浩珉、陳潔（2024），50萬筆華人最大基因資料庫TPMI，如何成為國安危機火藥庫？，報導者，載於：https://www.twreporter.org/a/taiwan-precision-medicine-initiative-controversy。 廖珮君（2023），醫指付APP爆盜刷 誰外洩個資？金管會要釐清，經濟日報，載於：https://money.udn.com/money/story/5613/7434691。 二、英文部分 （一）書籍 Ezrachi, Ariel & Stucke, Maurice E. 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