Cross-Platform Information Sharing from the Perspective of U.S. Antitrust Law—Focusing on Electronic Health Data Controllers
作者：李宇宸；陳鋕雄
出版年月日：202503
關鍵詞：資訊封鎖；21世紀醫療法；電子健康資料；跨境健康資料流通；HIPAA；Information Blocking；21st Century Cures Act；Electronic Health Information；Cross-border Health Data Flow；Health Insurance Portability and Accountability Act (HIPAA)
中文摘要
資料控制者透過蒐集、處理資料，能夠深入瞭解用戶的行為模式、偏好，特別是在生醫領域，大量電子健康資料的蒐集與處理，能協助瞭解致病機制、用藥時機以及臨床診斷，達成精準醫療的目標。由此可見，醫療資訊的廣泛持有已然是各家企業追逐的目標。
然而，在當今高度競爭的商業環境下，資料控制者通常不願無償提供其資料給競爭對手，該行為可能出於維護競爭優勢、保護用戶的資料安全等等原因，然而，無論是出於何種原因，平台業者拒絕分享資料的行為已對於跨平台間資訊流通產生阻礙。美國雖有《1996年醫療保險可攜性和負責性法》（Health Insurance Portability and Accountability Act of 1996, HIPAA）保障患者跨機構傳輸資料的權利，使患者面對資訊封鎖行為時能透過HIPAA解決，然商業機構如藥廠、生技公司面對資訊封鎖行為時仍束手無策。我國商業機構所面臨的處境更加艱難，我國不僅沒有針對資訊封鎖行為的相關法律，在現行法的限制下，商業機構無法取得電子健康資料。
商業機構無法自由取用電子健康資料的結果，大大地阻斷了新醫藥產品的發現、研發、生產，也拖慢了整體生醫領域的發展，因此「資訊封鎖行為」，特別是「生醫資訊封鎖行為」於我國是一個迫切需要解決的問題。
在管制此類「資訊封鎖」行為上，目前在學界廣為討論的有「個資法制」和「競爭法制」兩條路徑：歐洲議會所制定之一般個人資料保護規則（General Data Protection Regulation, GDPR）第22條可作為「個資法制」路徑之代表，認為資料主體具有將其資料在跨平台間傳遞之權利，又名資料可攜權（Data Portability），為其個人基本權利的延伸；而美國國會所制定之《21世紀醫療法》（21st Century Cures Act）可作為「競爭法制」路徑之代表，其係站在保護市場競爭的角度，明文強制資料控制者須將其所擁有之資料傳遞給其他競爭對手，以維持其等在市場上之相等地位。值得注意的是，美國《21世紀醫療法》的立法目的係以加速新醫藥產品的發現、研發、生產，因此其內容更著重在營利機構取得電子健康資料的權利上，與本文欲解決生醫資訊封鎖行為，以促進整體生醫產業發展不謀而合。
本文以競爭法角度切入此問題，以美國法為討論核心，輔以歐盟法，探討現行競爭法能否處理資訊封鎖行為，比如，系爭事業有無獨占地位是否為競爭法規範對象之門檻；若不具獨占地位之資料控制者從事了資訊封鎖行為，是否可能不受現行競爭法所規範；以及關鍵設施理論得否作為另一種解決方式。而在法律效果部分，欲回復市場競爭所為的措施是否真的能恢復市場原先狀態，回復措施是否適合電子健康資料控制者所處的市場亦為本文討論的一大重點。
在討論完上述「能否以競爭法解決資訊封鎖行為？」的三層問題後，本文會以美國《21世紀醫療法》作為借鑑，分析競爭法上之特別法在促進跨平台資訊交流的可行性，探討該法案實施後是否對美國的電子健康資料交流有所助益、降低資訊封鎖行為、促進營利機構運用電子健康資料等實質影響，期望能推動各界在競爭法路徑上的思考，逐步放寬營利機構取得電子健康資料的限制，以作為我國未來立法上之參考。
英文摘要
The data controller, through the collection and processing of data, can gain in-depth insights into user behavior patterns and preferences, especially in the biomedical field where extensive electronic health data collection and processing can assist in understanding disease mechanisms, timing of medication administration, and clinical diagnoses, ultimately achieving the goal of precision medicine. It is evident that the widespread possession of medical information has become a coveted objective for various enterprises.
However, in today’s highly competitive business environment, data controllers are often reluctant to provide their data to competitors free of charge. This behavior may stem from reasons such as maintaining a competitive advantage or safeguarding user data security. Nevertheless, regardless of the rationale, the refusal of data controllers to share data has created obstacles to information flow across platforms. Although the United States has Health Insurance Portability and Accountability Act of 1996, HIPAA to protect patients’rights to transmit data across institutions, enabling patients to address information blockade behavior through HIPAA, commercial entities such as pharmaceutical companies and biotech firms remain powerless when facing information blockade behavior. The situation for commercial entities in our country is even more challenging. Not only does our country lack relevant laws specifically targeting information blockade behavior, but under current regulations, commercial entities are unable to access electronic health data.
The inability of commercial entities to freely access electronic health data significantly hampers the discovery, research, and production of new medical products, thereby slowing down the overall development of the biomedical field. Therefore,“information blockade behavior,”especially“biomedical information blockade behavior,”is an urgent problem that needs to be addressed in our country.
In regulating such“information blocking”behavior, two pathways widely discussed in academia are the“personal data legal framework”and the“competition legal framework”. The General Data Protection Regulation (GDPR) enacted by the European Parliament, specifically Article 22, serves as a representative of the“personal data legal framework”pathway, recognizing the right of data subjects to transfer their data across platforms, also known as data portability, as an extension of their fundamental rights. On the other hand, the 21st Century Cures Act enacted by the US Congress serves as a representative of the“competition legal framework”pathway. From the perspective of preserving market competition, it expressly mandates data controllers to transfer their data to other competitors to maintain equal footing in the market. It is worth noting that the legislative purpose of the U.S. 21st Century Cures Act is to accelerate the discovery, research, and production of new medical products. Therefore, its content focuses more on granting profit-making entities the right to access electronic health data, which aligns with the aim of this article to address biomedical information blockade behavior and promote the overall development of the biomedical industry.
This article approaches the issue from a competition law perspective, with the discussion centered on U.S. law supplemented by EU law, to explore whether current competition law can address information blockade behavior. For example, whether possessing a dominant position is a threshold for competition law regulation; if data controllers who do not hold a dominant position engage in information blockade behavior, whether they may not be subject to current competition law regulations; and whether the essential facilities doctrine can serve as an alternative solution. In terms of legal effects, a key focus of this article is whether measures aimed at restoring market competition can truly revert the market to its original state, and whether these measures are suitable for the market in which electronic health data controllers operate.
After discussing the three-tiered question of“whether competition law can address information blockade behavior”, this article will use the U.S. 21st Century Cures Act as a reference to analyze the feasibility of special legislation in competition law to promote cross-platform information exchange. It will explore whether the implementation of this act has benefited electronic health data exchange in the United States, reduced information blockade behavior, and facilitated profit-making entities’utilization of electronic health data. The article aims to stimulate discussions across various sectors regarding the competition law approach, gradually easing restrictions on profit-making entities’access to electronic health data and serving as a reference for future legislative efforts in our country.
