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研究生： 張揚理
Chang, Yang-Lee.
論文名稱： 論人工智慧醫療軟體之法規管制— 以美國及歐盟法為中心
Regulating Artificial Intelligence-Based Medical Software: A Comparative Study on Law of the United States and the European Union
指導教授： 林勤富
Lin, Ching-Fu
口試委員: 范建得
Fan, Chien-Te
江浣翠
Chiang, Wan-Tsui
學位類別： 碩士
Master
系所名稱： 科技管理學院 - 科技法律研究所
Institute of Law for Science and Technology
論文出版年： 2021
畢業學年度： 109
語文別： 中文
論文頁數： 117
中文關鍵詞： 人工智慧 、醫療軟體 、醫療器材 、管制理論 、管制架構 、美國食品藥物管理署 、歐盟醫療器材規則 、歐盟人工智慧管制規則草案
外文關鍵詞： artificial intelligence, medical software, medical device, regulatory theory, regulatory structure, USFDA, MDR, AI Act
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    • 近年來「智慧醫療」皆被各國政策列為重要的發展項目，人工智慧技術不但有望解決醫療體系人力短缺及資源分配不均的情形，甚至能幫助人們帶來更精準的治療方案、更低成本的醫療花費及更高品質的醫療照護。然而，人工智慧技術並非完美無缺，尤其不透明運作的本質，現存法規亦難以有效掌握並減低其風險。目前，在醫療領域最常被應用的人工智慧技術，係以「醫療軟體」形式分析輸入之健康資訊，提供醫護人員診斷及治療上之輸出建議。以美國及歐盟法規為例，皆為將醫療軟體納入「醫療器材」範圍管制，惟目前醫療器材法規並無為人工智慧特性所設計之管制措施，學者亦紛紛提出應為人工智慧醫療軟體管制，進行法規上的革新。人工智慧醫療軟體作為醫療產品之一種，本文主要關注其安全性及有效性之管制，檢視近年相關法規管制上有何變革，更進而思考管制上更適切的作法。
    本文首先觀察人工智慧應用於醫療場域之情形，包含其應用於醫療之目的、種類，以提出其作為一項醫療產品，於法規管制上之正當性、連結性及有效性相應之挑戰。其次，檢視美國及歐盟近年來於醫療器材法規上之增修，以及針對人工智慧醫療軟體所發布之政策文件及法律草案，並以管制主體、管制客體及管制方法三個面向，評析其於管制上的特點及優劣。最後，本文對於美國及歐盟在人工智慧醫療軟體之管制上進行比較分析，並結合法律及科學領域之學者文獻，提出法規對於人工智慧醫療軟體管制上得以加強之處，本文亦提出兩點管制建議：電子健康資料之整合及運用、以及多方參與而行政機關主導之管制，以供管制者參照。

    In recent years, many countries have prioritized the development of artificial intelligence (AI) technology in healthcare. AI can bring positive changes, though, it is not a perfect solution, especially when it comes to its much-debated black box nature and other unknown risks that are beyond the capabilities of the current legal system. At this stage, AI in healthcare mostly appears in the form of “medical software” that generates advice for medical professionals. In the US and the EU, medical software is regulated as a “medical device,” yet the current legislation lacks mechanisms designed for the regulation of AI. Many scholars have urged to establish a new model for regulating AI-based medical software. By scrutinizing relevant law reforms in recent years, this Thesis aims to explore more appropriate solutions that can ensure the safety and effectiveness of AI-based medical software.
    First, through examining how AI is used in the medical field, including the purposes and the types of AI-based medical software, this Thesis identifies the regulatory challenges of such software in the aspects of legitimacy, effectiveness, and connection. Furthermore, this Thesis analyzes the pros and cons of current approaches in terms of the regulatory body, object, and method after studying the reforms of medical devices law in the US and the EU, and regulation proposals targeting AI-based software. This Thesis also conducts a comparative study on US and EU regulations of AI-based medical software, and argues that some issues have not been fully addressed. Finally, this thesis proposes two solutions, namely integrating electronic health data and introducing a government-led model that is participated by multiple parties.

    摘要 i Abstract ii 謝辭 iii 目錄 v 第一章、緒論 1 第一節、問題意識 1 第二節、文獻回顧 4 第三節、研究方法 9 第四節、研究範圍與限制 10 第一項、管制主體範圍 10 第二項、管制客體範圍 11 第三項、管制方法範圍 14 第五節、研究架構 14 第二章、智慧醫療之目的、種類及管制挑戰 16 第一節、人工智慧技術之特性 16 第一項、不透明性 17 第二項、應用過程變動性 19 第二節、人工智慧於醫療領域之應用目的 20 第一項、個人化精準醫療 20 第二項、有效分配醫療資源 21 第三項、加速醫學研究進程 22 第三節、人工智慧醫療產品應用種類 22 第一項、醫療影像判讀 23 第二項、臨床決策輔助 23 第三項、行動應用程式 24 第四項、體外診斷測試 25 第五項、醫療行政管理 26 第四節、人工智慧醫療產品之管制挑戰 28 第一項、管制必要性 28 第二項、管制困難 29 第三章、美國人工智慧醫療軟體管制規範 32 第一節、軟體作為醫療器材之法規演變 32 第一項、美國醫療器材法規簡介 32 第二項、21世紀醫療法的變革 34 第二節、人工智慧軟體醫療器材管制架構 37 第一項、軟體醫療器材之管制 37 第二項、人工智慧醫療軟體管制 40 第三節、智慧醫療軟體管制種類 43 第一項、臨床決策輔助軟體 44 第二項、移動醫療應用程式 45 第三項、實驗室自行研發檢驗技術 47 第四節、醫療資料管制 48 第五節、美國人工智慧醫療軟體管制架構評析 50 第一項、管制主體評析 50 第二項、管制客體評析 52 第二項、管制方法評析 54 第四章、歐盟人工智慧醫療軟體管制規範 57 第一節、歐盟醫療軟體管制架構 58 第一項、醫療軟體屬於醫療器材之管制變革 58 第二項、醫療器材法中醫療軟體規範 62 第二節、歐盟人工智慧管制規則草案 66 第一項、立法背景及目的 66 第二項、高風險人工智慧系統 67 第三節、醫療資料管制 69 第四節、歐盟人工智慧醫療軟體管制評析 71 第一項、管制主體評析 71 第二項、管制客體評析 75 第三項、管制方法評析 77 第五章、歐美人工智慧醫療軟體規範比較分析與管制建議 80 第一節、美國及歐盟管制比較分析 80 第一項、管制主體比較分析 83 第二項、管制客體比較分析 85 第三項、管制方法比較分析 88 第二節、歐美人工智慧醫療軟體管制不足之處 90 第一項、更新問題 90 第二項、臨床驗證 92 第三項、可解釋性 94 第四項、誘因保護 97 第三節、人工智慧醫療軟體管制建議 99 第一項、電子健康資料之整合及運用 100 第二項、多方參與而行政機關主導之管制 102 第六章、結論—兼論台灣人工智慧醫療軟體未來管制方向 106 參考文獻 108

    一、中文文獻
    1. 專書
    黃偉峰主編（2007），《歐洲聯盟之組織及運作》，第二版。
    2. 文章
    王泰銓，（2019），〈關於歐盟法規範的名稱翻譯、條款引用與適用上的問題〉，歐洲萬象，請參閱: https://www.eusa-taiwan.org.tw/europe_detail/65.htm。
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    3. 網路資源
    王泰銓，關於歐盟法規範的名稱翻譯、條款引用與適用上的問題，台灣歐洲聯盟研究協會，2019年2月1日，https://www.eusa-taiwan.org.tw/europe_detail/65.htm（最後瀏覽日：2021年8月20日）。
    二、英文文獻
    1. Books
    ARTIFICIAL INTELLIGENCE IN HEALTH CARE: THE HOPE, THE HYPE, THE PROMISE, THE PERIL (Michael Matheny et al. eds., 2019).
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    Adarsh Subbaswamy & Suchi Saria, From Development to Deployment: Dataset Shift, Causality, and Shift-Stable Models in Health AI, 21(2) BIOSTATISTICS 345 (2020).
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    3. USFDA Documents
    Digital Health Software Precertification (Pre-Cert) Program, U.S. FOOD & DRUG ADMINISTRATION (May 6 2021), https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program (Last visited August 14, 2021).
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    4. EU Documents
    Commission Guidelines MEDDEV 2.1/6 on the Qualification and Classification of Stand Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices (July 15, 2016), https://ec.europa.eu/docsroom/documents/17921/attachments/1/translations (Last visited August 13, 2021).
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    Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation No 178/2002 and Regulation No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, 2017 O.J. (L117).
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    5. Cases
    Case C-120/78, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein ('Cassis de Dijon’) 1979, E.C.R. 42.
    Case C-219/15, Elisabeth Schmitt v. TÜV Rheinland LGA Products GmbH, 2017 E.C.R. 128.
    Case C-329/16, Syndicat national de I’industrie de technologies médicales (SNITEM) & Philips France v. Premier Minister and Ministre de Affairs sociales et de la Santé, 2017 E.C.R. 947.
    Diamond v. Diehr, 450 U.S. 175 (1981).
    Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).
    Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014).
    6. Websites
    ABBYY Accelerates U.S. Food and Drug Administration’s Public Health Initiatives, ABBYY (October 20, 2020), https://www.abbyy.com/company/news/abbyy-accelerates-usa-food-and-drug-administrations-public-health-initiatives/ (Last visited August 14, 2021).
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