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以 Apple Watch 相關功能之爭議為例
The widespread use of smartphones, tablets, and smartwatches has led to the rapid growth of healthcare and medical apps. These apps are popular with consumers and healthcare professionals for their convenience, personalized health management features, and low cost. However, their medical functions have raised regulatory concerns. For example, in Taiwan, the ECG function on the Apple Watch is classified as a medical device and subject to restrictions, while the blood oxygen measurement function can be used freely, highlighting inconsistencies in regulations. This article examines the regulation of mobile healthcare apps, focusing on differences between the U.S. and Taiwan and the potential risks of misleading advertising.
Mobile healthcare apps can be divided into four categories:
1. Apps that connect to medical devices to control operations, such as hearing aid calibration or heart implant monitoring.
2. Apps that turn mobile devices into medical tools, like audiometers for diagnosing ear conditions or tools for detecting sleep apnea.
3. Apps that actively monitor patients and analyze medical data, providing real-time updates or alerts to support medical decisions.
4. Apps for managing everyday health, such as tracking health metrics or managing sleep and stress, without diagnosing or treating diseases.
This discussion focuses on apps used by individuals without healthcare professionals. Since these apps can pose health risks, proper regulation is crucial. The U.S. leads in both market size and regulation, and Taiwan has adopted some FDA guidelines.
In the U.S., the FDA and FTC oversee mobile healthcare apps. The FDA categorizes them as non-medical, low-risk medical, or fully regulated medical devices. The 2016 21st Century Cures Act clarified that some apps are not considered medical devices. The FDA encourages rapid product launches through guidelines and the Digital Health Software Precertification Program. The FTC monitors the market for false advertising and consumer fraud and helps businesses with compliance.
In Taiwan, ECG apps require approval as medical devices, similar to U.S. standards. Apple gained this approval in 2020, allowing the ECG function to be available in Taiwan. Despite concerns about its effect on sales, Taiwan’s licensed pharmaceutical channels and online platforms can legally sell medical devices.
Taiwan’s regulations, though based on U.S. standards, are less detailed, which may cause confusion between industry players and regulators. The FDA provides more specific examples in its guidelines, whereas Taiwan’s are brief. Furthermore, Taiwan lacks the cross-agency cooperation seen in the U.S., impacting regulatory efficiency.
In terms of data protection, Taiwan’s efforts are minimal, and the U.S. HIPAA framework also faces challenges. Future attention should focus on the U.S. Precertification Program’s impact on long-term product safety and the reliance on self-regulation by companies.
Translation 中文翻譯
智慧裝置如智慧手機、平板電腦和智慧手錶的廣泛使用,促使醫療和健康應用程式迅速增長。這些應用程式因其便捷性、個性化健康管理功能和低成本,受到消費者和醫療專業人士的青睞。然而,這些應用程式的醫療功能也引發了法規上的爭議。例如,Apple Watch的心電圖功能在臺灣被視為醫療器材,需受到相關限制,而血氧濃度測量功能則可直接使用,顯示了法規適用上的矛盾。本文探討了行動醫療應用程式的管理和規範,特別是美國和臺灣在這方面的差異,以及消費者可能面臨的廣告誤導問題。
行動醫療應用程式主要可分為以下四類:
1. 連接現有醫療器材以控制操作的應用程式
如助聽器校準或心臟植入器的監控。
如助聽器校準或心臟植入器的監控。
2. 將行動裝置轉變為醫療器材的應用程式
如診斷耳科疾病的聽力計或睡眠呼吸暫停檢測工具。
如診斷耳科疾病的聽力計或睡眠呼吸暫停檢測工具。
3. 主動監控病患狀況並分析醫療數據的應用程式
用於遠程監視病患的健康狀況,提供即時資訊或警示以輔助醫療決策。
用於遠程監視病患的健康狀況,提供即時資訊或警示以輔助醫療決策。
4. 處理日常健康情形的應用程式
主要用於個人健康管理,如記錄健康指標、管理壓力和睡眠,不涉及疾病診斷或治療。
主要用於個人健康管理,如記錄健康指標、管理壓力和睡眠,不涉及疾病診斷或治療。
本篇主題集中在無需醫事人員參與,由個人自行使用的行動醫療應用程式。由於個人使用的應用程式可能帶來不同的健康風險,因此其規範尤為重要。美國在這一領域的管理規範和市場規模全球領先,臺灣的規範也受到美國FDA的影響。 美國對行動醫療應用程式的管理主要由FDA和FTC負責。FDA根據《聯邦食品藥物及化妝品法》將應用程式分為三類:非醫療器材應用程式、低風險醫療器材應用程式和需常規管理的醫療器材應用程式。2016年《21世紀醫療法》進一步明確部分應用程式不屬於醫療器材範疇。FDA通過指引文件和「數位健康軟體預先認證計畫」推動創新產品的快速上市。FTC則專注於上市後的市場監管,尤其打擊不實廣告和消費者欺騙行為,並提供跨部門協作的資源,幫助廠商降低法令遵循的難度。
臺灣的醫療器材管理現況顯示,心電圖應用程式涉及醫療診斷,需申請醫療器材許可,這與美國的要求相符。蘋果公司於2020年獲得許可後,該應用程式在臺灣正式上架。雖然有論者擔心這會影響銷售,但臺灣已有藥商許可證的通路可以銷售醫療器材,網路販售亦被允許。
在指引的明確性方面,臺灣的相關規範雖借鑒美國,但仍顯得簡要且缺乏具體實例,可能導致業者與主管機關之間的理解差異。美國FDA的指引提供了大量具體產品範例,而臺灣的指引則相對簡略。除此之外,臺灣缺乏類似美國FTC和FDA的跨部門合作,影響了法規遵循的效率。
關於個人資料保護問題,臺灣目前的管理措施較為消極,而美國的HIPAA也面臨挑戰。未來應關注美國的預先認證計畫及其對產品安全性的長期影響,並對其基於業者宣稱的管制邏輯進行深入研究。
CHECK THIS OUT 學習知識點
‘Taiwan’s regulations, though based on U.S. standards, are less detailed, which may cause confusion between industry players and regulators.’
Here we have a sentence with a non- defining relative clause, the clause which comes after ‘which’. Here we are putting extra information which is not essential information after ‘which’. The information in the relative clause gives more extra information about the subject of the first clause, ‘Taiwan’s regulations.’
「臺灣的相關規範雖借鑒美國,但仍顯得簡要且缺乏具體實例,可能導致業者與主管機關之間的理解差異。」
這裡我們有一個帶有非限定性關係子句的句子,該子句位於「which」之後。在這裡,我們將非必要資訊的額外資訊放在「which」之後。相關子句中的資訊提供了有關第一個子句「台灣法規」主題的更多額外資訊。
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