從醫療資訊治理檢視智慧醫療下的病人權利

Data Laws and Patient Rights in Smart Healthcare

面對當前醫療環境中諸多存在的挑戰，智慧醫療（即人工智慧應用於醫療）作為現有醫療體系的技術進展之一，可能對現存問題產生解決或加劇的效果，隨著人類對醫療服務需求的持續增長，醫療領域的技術與服務亦將持續演進，而醫療與科技的結合不過順應時代潮流發展，並非創新之舉。本文基於當前醫療領域之法規範，探討資訊技術進入醫療領域後之影響，在硬體與軟體層面的變化對法律更新之必要性，包含醫院建築配置、資訊安全、全民健康保險資料與其他醫療資訊的使用授權等項目，而所受影響的法規有《個人資料保護法》、《人體生物資料庫管理條例》、《醫療法》、《醫師法》、《通訊診察治療辦法》……等等，在資料的使用、轉移及目的外使用等操作方面，雖有《個人資料保護法》作為規範基準，然而各項特別法在規範範疇與程度上有所不同，因此進行全面性檢討，以促進各法規間的協調性，乃為必要之舉。
綜觀醫療資訊從取用到刪除的生命歷程，一共有政府機關、醫療服務提供者及研究者、醫療資訊提供者等三方，與醫療資訊有最密切的互動，又其中以醫療資訊提供者通常處於相對弱勢地位，難以有效主張其合法權益，因此本文以醫療資訊提供者的權利為中心，探討法制的更迭是否顧及病人、受試者、捐獻者等等主動或被動提供醫療資訊之人的最佳利益。

In today’s healthcare environment, which faces numerous existing challenges, smart healthcare can serve either as a solution or a complicating factor; nevertheless, it remains merely one component of ongoing technological advancement. As long as humanity’s demand for medical care persists, the pursuit of progress will continue. The integration of healthcare and technology is thus a natural response to the trends of the times, rather than a novel concept. This article, grounded in current medical regulatory frameworks, examines the necessary legal updates arising from technological interventions in the medical field, considering both hardware and software developments. Areas of focus include hospital infrastructure, information security, authorization for the use of health and welfare data, and other medical information. The relevant regulations including the Personal Data Protection Act, the Human Biobank Management Act, the Medical Care Act, the Physicians Act, and the Regulations of Treatment on Telemedicine, among others. Although the Personal Data Protection Act serves as the baseline framework for data utilization, transfer, and use outside of its original purposes, the scope and level of regulation differ among various special laws. Thus, a comprehensive review is essential to enhance coordination among these legal frameworks.
From the perspective of the lifecycle of medical information—from collection to deletion or destruction—three primary parties interact closely with such data: government agencies, medical service providers and researchers, and medical information providers. Among these, medical information providers are the most disadvantaged group, often lacking the means to assert their rights. This article therefore centers on the rights of medical information providers, assessing whether evolving legal frameworks adequately safeguard the best interests of patients, research participants, donors, and others who actively or passively provide medical data.