By  Kuo-Hsun Hong, Partner of Formosan Brothers Attorneys-at-Law

Pei-Yuan Wei, U.S. New York Bar Admitted

According to foreign news sources, during the final days of his cancer treatment, Steve Jobs was very unhappy about the health monitoring device used to treat him. We do not know if his experience guided the direction of Apple’s subsequent product development. Yet, along with the advancement of technology and the recent impact from COVID-19, many patients and people with health concerns are seeking means for remote medical services to reduce the risk of infection. Innovations in portable devices seem to point out a direction for this type of medical demand.

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The use of portable devices seems to increase the likelihood of realizing distance medical care or diagnosis, increasing the patient’s scope of mobility, reducing medical costs, and enhancing the quality and efficiency of medical care through comprehensive recording and monitoring. However, in addition to technical issues such as accuracy, timeliness, and hygiene, more administrative controls will be imposed on portable devices to ensure public health and safety. Moreover, there are afloat of legal uncertainties regarding portable medical devices with regard to patients’ personal data protection.

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Take Apple Watch Series 4 as an example, due to its claims for fall detection and ECG capabilities, Apple Watch Series 4, after an extended application process, was finally approved by the USFDA (U.S. Food & Drug Administration or “FDA”) in 2018 as a Class II medical device. However, for the recently released Apple Watch Series 6, although it has an additional blood oxygen detection functionality, while pulse oximeter is also a Class II medical device, this time, the FDA did not require Apple to apply for approval.

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The main reason is, this time, Apple did not claim the capability of diagnosing atrial fibrillation (“AFib”) as they did for Apple Watch Series 4. They only emphasized that blood oxygen detection was only meant as entertainment or wellness. For this reason, Apple Watch Series 6 did not need FDA approval before selling.

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Compared to the above, in Taiwan, medical equipment related regulations do not distinguish those for “treatment or diagnosis” and those for the so-called “entertainment or wellness.” Paragraph 1 of Article 3 of the Medical Devices Act states, “The term ‘medical devices’, as used in this Act, shall refer to instruments, machines, apparatus, materials, software, reagents for in vitro use, and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by other than pharmacological, immunological, metabolic, or chemical means: 1. Diagnosis, treatment, alleviation, or direct prevention of human diseases. 2. Modification or improvement of the structure and function of human body. 3. Control of conception.” That is, whether it is an ECG management system, a diagnostic and warning device for arrhythmia, programmable diagnostic computer (can be programmed to compute various physiological or blood flow parameters using the output of multiple electrodes, transmitters, or sensors; including any related applications on the market), a preprogrammed diagnostic computer with single functionality, a physiological signal oscilloscope (physiological vibration equipment detecting changes such as arterial blood volume) or a non-invasive pulse oximeter for sports and aviation, such device is categorized as medical equipment. To make available any of the above capabilities on an Apple Watch, a medical device business permit from the Taiwan FDA is required. Therefore, when such a permit has not been obtained in the past, such capabilities will be disabled by the company. As a result, consumers in Taiwan and some other regions could not use such featured functionalities. However, this issue may be resolved after Apple appointed an agent in Taiwan to apply for a medical device business permit (Wei-Bu-Yi-Chi-Shu-Zi No. 033901－“Apple” ECG App), and consumers in Taiwan may finally get to enjoy such features.

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In terms of the policy, we wonder if the Taiwanese government can loosen its control as the USFDA did, such as defining the functionalities a medical device is allowed to claim, and if a medical device business permit has not been obtained, such a device cannot claim to have such functionality. If the device simply provides data for entertainment or daily recording purposes and a warning is required to be placed on the device, this will segregate the medical device market from the common consumer market, and it seems that this will not necessarily create chaos or loopholes with respect to regulatory control. After all, it does not seem fair when consumers in Taiwan purchase the same product at the same or equivalent price but cannot use the same functionalities of the product. At the same time, the loosening of control will allow consumer electronics manufacturers and retailers to decide for themselves, according to their operational and market positioning demands, whether to be bound by relevant regulations for medical device manufacturers and medical device distributors and in turn, promote the development and competition for related products.

(This article was published in the Expert Commentary Column of the Commercial Times. https://view.ctee.com.tw/legal/24843.html )

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