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LATEST LEGAL NEWS
MOEA enacts the Regulations for the Management of the Permission of Selling Hydrogen Fuel by Hydrogen Refueling Stations

Background

To achieve the Paris Agreement’s goal of limiting global warming to 1.5°C and to respond to global energy crises, hydrogen is emerging as a major energy source of choice. However, more policies are needed to promote the cleaner use of hydrogen in heavy industries and long-haul transport. In the report Global Hydrogen Review 2022, the International Energy Agency suggested several policy recommendations to expedite the global adoption of hydrogen: 1. Enhance economic viability for low-emission hydrogen; 2. Create low-emission hydrogen demand; 3. Accelerate infrastructure development; 4. Strengthen international cooperation in hydrogen trade; and 5. Eliminate regulatory barriers, clarify market rules, and improve licensing efficiency and coordination.

In December 2022, the Ministry of Economic Affairs(MOEA, 經濟部) launched the “Key Strategic Action Plan: Hydrogen(氫能關鍵戰略行動計畫)”, as one of the 12 Key Strategies(十二項關鍵戰略) on the path to net-zero emissions by 2050. This action plan sets project goals, paths, overall performance indicators, and an implementation timeline. It is the first official document in Taiwan to feature specific actions for promoting hydrogen energy development.

The Regulations for the Management of the Permission of Selling Hydrogen Fuel by Hydrogen Refueling Stations

On July 4, 2023, the MOEA has designated hydrogen fuel as the energy source under subparagraph 6, article 2 of the “Energy Administration Act(能源管理法)”. On November 1, 2023, as authorized under paragraph 3, Article 6 of the Energy Administration Act, the MOEA enacted the "Regulations for the Management of the Permission of Selling Hydrogen Fuel by Hydrogen Refueling Stations (加氫站銷售氫燃料經營許可管理辦法). These regulations specify locations, applications, facilities, safety distances, operations, periodic autonomous inspections, etc. for hydrogen fuel stations, as well as sales and management of hydrogen fuel. The regulations are aimed at creating safe environments and robust management systems for hydrogen refueling stations.

However, the entire regulatory framework for hydrogen requires further development, especially in terms of integrating critical components of hydrogen infrastructure, including production, storage facilities, and transmission equipment. These elements involve diverse functionalities and technologies, and so will necessitate a more comprehensive regulatory framework to ensure safety and efficient operation throughout the hydrogen energy lifecycle. In addition, the lack of comprehensive safety regulations may lead to inconsistent safety standards, raising public concerns about safety risks and diminishing investor confidence, and limiting the development of hydrogen technology and infrastructure.

Next Steps

To address these issues, the “Key Strategic Action Plan: Hydrogen” provides ample information to the public, aiming to deepen understanding of hydrogen’s technologies and safety. The plan also urges that the CPC Corporation Taiwan (台灣中油公司) take fire safety and installation security into account with regard to hydrogen installation, storage, and use; and requires that installations must respect the land use and environmental protection regulations, and comply with domestic safety laws and fire safety measures.

[1] International Energy Agency [IEA], Global Hydrogen Review 2022 (2022), https://www.iea.org/reports/global-hydrogen-review-2022 (last visited Nov. 14, 2023).
[3] 科技部,〈綠能科技聯合研發計畫 〉,行政院網站,https://www.ey.gov.tw/File/FCCF5A2D476D6F1 (最後瀏覽日:2023/11/15)。
[5] 能源管理法第2條第6款。
[6] 加氫站銷售氫燃料經營許可管理辦法。
 
Financial Supervisory Commission releases the Core Principles and Policies for AI Applications in the Financial Industry

The Financial Supervisory Commission (FSC, 金融監督管理委員會) released the Core Principles and Policies for AI Applications in the Financial Industry (金融業運用人工智慧(AI)之核心原則與相關推動政策) document on October 17, 2023 to assist financial institutions in leveraging the benefits of AI technology, and to effectively manage risks, ensure fairness, protect consumer rights, maintain system security, and achieve sustainable development.

The FSC consulted international practices and integrated FSC’s supervision policy concepts such as responsible innovation, strengthening legal compliance, fair hospitality, inclusive finance, information security, information disclosure, sustainable finance, and caring for employees. The FSC has now announced six core principles for AI applications in the financial industry, and has put forward supporting policies in response to the development and promotion of AI.

1. Core Principles for AI Applications in the Financial Industry

● Principle 1: Establishing governance and accountability mechanisms
Financial institutions should assume all corresponding internal and external responsibilities for the AI systems they use; establish comprehensive, effective AI risk management mechanisms; and ensure that their employees have sufficient knowledge and capabilities to implement appropriate risk-based decisions and supervision.

● Principle 2: Emphasizing fairness and human-centric values
When implementing AI systems, financial institutions should, to the greatest extent possible, strive to mitigate algorithmic bias, and adhere to the principle of being human-centric. Institution employees should still manage the risks of information generated by generative AI.

● Principle 3: Safeguarding privacy and customer rights
Financial institutions should protect consumer privacy, properly manage and use customer data; they should also respect customers’ right to choose whether or not to use AI services, and inform customers regarding alternative options.

● Principle 4: Ensuring system robustness and security
Financial institutions should prevent the AI systems they use from causing harm to consumers or the financial system, and should conduct proper risk management and supervision of third-party operators.

● Principle 5: Implementing transparency and explainability
Financial institutions should ensure transparency and explainability in AI system operations, to allow effective evaluation and management of AI risks. When institutions use AI to interact directly with consumers, they should appropriately disclose information about such interaction. They should also ensure that the degree of explainability is commensurate with the importance of the AI system applications, allowing those adversely affected to challenge the results of the AI output.

● Principle 6: Promoting sustainable development
When financial institutions use AI systems, they should ensure that their development strategies and implementations promote inclusive growth, sustainable development, and social welfare. It is also best that appropriate education and training be provided to institution employees.

2. FSC Policies in Response to the Development of AI

The FSC resolves to:

(1) Issue the Guidelines for AI Applications in the Financial Industry, based on six core principles, to promote the development of the financial industry, and to safeguard system stability and consumer rights.

(2) Continuously review related regulations and make timely adjustments thereto, in order to create a robust regulatory environment for AI applications.

(3) Use AI technology to develop supervision technology (SupTech) and thus enhance the efficiency of financial supervision.

(4) Engage in international exchanges and collaboration, to ensure that supervision policies stay in line with international trends.

(5) Encourage the financial industry to participate in AI research, development, and applications, in order to provide quality services or develop regulatory technology (RegTech), and to assist financial institutions in introducing best practices.

(6) Continuously oversee financial institutions’ regulatory compliance and risk management, in order to enhance public trust and social welfare.

(7) Instruct the financial industry associations to establish self-regulatory standards and best practices for AI system usage.

(8) Supervise financial institutions’ implementation of fair customer treatment and compliance with friendly financial guidelines, so as to reduce the digital divide and ensure a fair transformation of digital finance.

[1] <金管會公布金融業運用人工智慧(AI)之核心原則及政策>,金融監督管理委員會,https://www.fsc.gov.tw/ch/home.jsp?id=96&parentpath=0,2&mcustomize=news_view.jsp&dataserno=
202310170002&dtable=News
(最後瀏覽日︰2023/10/31)。
[3] Financial Supervisory Commission [FSC], The FSC publishes core principles and policies for AI applications in the financial industry (2023), https://www.fsc.gov.tw/en/home.jsp?id=54&parentpath=0,2&mcustomize=multimessage_view.jsp&dataserno=202311070001&dtable=News (last visited Nov. 13, 2023).
 
MOHW submits draft Regulations of Medical Diagnosis and Treatment by Telecommunications amendment to improve medical service accessibility

Background

In accordance with Article 11 of Taiwan’s Physicians Act, in principle, a physician must do all medical examinations in person; otherwise, the physician “may not treat, issue prescription or certificate of diagnosis”. However, there are three exceptions where medical diagnosis and treatment via telecommunications (that is, “tele-medicine”) can be implemented: “In mountain areas, on outlying islands, and in remote areas”, under “special” and ”urgent” circumstances. Based on this authorization, Taiwan’s Ministry of Health and Welfare (the “MOHW”) announced the Regulations of Medical Diagnosis and Treatment by Telecommunications (the “Regulations”) on May 11, 2008. During the COVID-19 pandemic in 2020, the MOHW expanded the application of tele-medicine. This accelerated the development of tele-medicine. In preparation for future post-pandemic developments, the MOHW proposed a draft amendment to the Regulations on November 24, 2022.

Key points in the draft amendment

1.Amending and expanding the special circumstances for tele-medicine

The current Regulations cover only five specific situations:

I. For people given acute inpatient treatment, follow-up treatment within three months after their discharge from the hospital.

II. Chronic disease patients in institutional long-term care facilities.

III.Patients in need of integrated care by family physicians, where such care is stipulated by law.

IV. For people given government-approved home care, follow-up treatment within three months of initial care.

V. International medical care for foreign patients.

Based on pandemic experience, this draft amendment expands applicable circumstances to include the following 10 categories:

I. Post-acute care.

II. Long-term medication care for chronic diseases.

III.Long-term care services (expanded to include welfare institutions for the elderly and physically/mentally disabled, nursing facilities, etc.).

IV. Care received from a family physician.

V. Home medical care.

VI. End-of-life care.

VII. Care for those with mobility issues.

VIII.Care during disasters, infectious diseases, and other major incidents.

IX. International medical care.

X. Other situations specified by the competent authority.

2. Expanding the range of medical services for tele-medicine

The current regulations allow physicians, during tele-medicine consultations, to inquire on disease status, perform clinical exams, issue prescriptions and medical advice, adjust original prescriptions or advice, and deliver health education. This draft amendment expands the range of medical services to also include doing diagnosis, giving treatment instructions, ordering tests or examinations, and doing consultations and preventive healthcare.

3. Allowing tele-medicine physicians to prescribe medications, under certain conditions

In consideration that physicians may need to prescribe medications when doing tele-medicine, this draft amendment allows them to do so for the following patients:

I. Patients in stable condition who require follow-up: Patients who fall into categories 1–6 of the 10 special circumstances described above.

II.Patients who are doing a first visit or follow-up in the following circumstances: Patients in mountainous areas, outlying islands, and remote areas; patients falling into categories 7, 8, and 9 of the 10 special circumstances described above; and patients in urgent circumstances.

4. Strengthening information and communication security regulations for tele-medicine systems

Tele-medicine systems involve transmitting, exchanging, and storing medical records, as well as creating prescription, test, and examination documents. In consideration of this fact, this draft amendment requires that these systems must be equipped with personal identity verification, and must comply with the data transmission encryption scheme requirements specified by international standards organizations. They must also adhere to the stipulations of the Regulations for the Production and Management of Electronic Medical Histories by Medical Care Institutions.

5. Expanding locations where physicians can provide tele-medicine

Under the current regulations, physicians are restricted to providing tele-medicine at healthcare institutions. This draft amendment acknowledges that, in emergencies or special situations, there may be a need to conduct tele-medicine outside healthcare institutions. The amendment expands this to say that while tele-medicine should in principle be provided at healthcare institutions, it may be provided outside such institutions in exceptional circumstances.

The COVID-19 pandemic has led to increasing familiarity with tele-medicine among medical professionals and the general public. The widespread use of online communication, continuing advancement of technology, and the aging population are making tele-medicine a normal part of future healthcare. After the publication of this amendment, collaboration between healthcare institutions, primary care clinics, information technology companies, and other stakeholders will be necessary to provide patients with appropriate and comprehensive healthcare.

[1] MINISTRY OF HEALTH AND WELFARE [MOHW], “Draft Amendment to the Regulations of Medical Diagnosis and Treatment by Telecommunications” (2022), https://mohwlaw.mohw.gov.tw/DRAFT/DraftContent.aspx?msgid=11400&KW=%e9%80%9a%e8
%a8%8a%e8%a8%ba%e5%af%9f%e6%b2%bb%e7%99%82%e8%be%a6%e6%b3%95
(last visited Nov. 24, 2023).