Legal Aspects and Liability Issues Concerning Autonomous Ships
Legal Aspects and Liability Issues Concerning Autonomous Ships
All sectors of business and industry are transforming into digital society, and maritime sector is not out of the case. But the new thing is the remote control ships or fully automatics ships are becoming a reality.
Remote control ships and autonomous ships will be a tool to reach safety, effectiveness, and economical goal. However, as it intends to take over human element in the maritime industry, the implement of remote control ships or autonomous ships brings new legal issues and liability considerations.
This study aims to highlight some critical legal issues of autonomous ships to reader, but will not try to solve them or give clear answers.
I. The Approach of International Maritime Organization
In order to solve issues from the deployment of autonomous ship, International Maritime Organization Maritime Safety Committee (MSC) has taken first steps to address autonomous ships. In the meeting of MSC 100, the committee approved the process of assessing IMO instruments to see how they may apply to ships with various degrees of autonomy.
For each instrument related to maritime safety and security, and for each degree of autonomy, provisions will be identified when:
- apply to MASS and prevent MASS operations; or
- apply to MASS and do not prevent MASS operations and require no actions; or
- apply to MASS and do not prevent MASS operations but may need to be amended or clarified, and/or may contain gaps; or
- have no application to MASS operations.
The degrees of autonomy identified for the purpose of the scoping exercise are:
- Degree one: Ship with automated processes and decision support: Seafarers are on board to operate and control shipboard systems and functions. Some operations may be automated and at times be unsupervised but the seafarers on board are ready to take control.
- Degree two: Remotely controlled ship with seafarers on board: The ship is controlled and operated from another location. Seafarers are available on board to take control and to operate the shipboard systems and functions.
- Degree three: Remotely controlled ship without seafarers on board: The ship is controlled and operated from another location. There are no seafarers on board.
- Degree four: Fully autonomous ship: The operating system of the ship is able to make decisions and determine actions by itself.
The initial review of instruments under the purview of the Maritime Safety Committee will be conducted during the first half of 2019 by a number of volunteering Member States, with the support of interested international organizations. MSC working group is expected to meet in September 2019 to move forward with the process with the aim of completing the regulatory scoping exercise in 2020.
The list of instruments to be covered in the MSC’s scoping exercise for MASS includes those covering safety (International Convention for the Safety of Life at Sea, SOLAS); collision regulations (The International Regulations for Preventing Collisions at Sea, COLREG); loading and stability (International Convention on Load Lines, Load Lines); training of seafarers and fishers (International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, STCW); search and rescue (International Convention on Maritime Search and Rescue, SAR); tonnage measurement (International Convention on Tonnage Measurement of Ships, Tonnage Convention); Safe Containers (International Convention for Safe Containers, CSC); and special trade passenger ship instruments (Special Trade Passenger Ships Agreement, STP).
IMO will also develop guidelines on MASS trial. The guideline include ensuring that such guidelines should be generic and goal-based, and taking a precautionary approach to ensuring the safe, secure and environmentally sound operation of MASS. Interested parties were invited to submit proposals to the next session of the Committee for the future development of the principles.
II. Other Legal issues concerning Autonomous Ships
In March 2017, the (Comité Maritime International, CMI) Working Group on Unmanned Ships circulated a questionnaire. The questionnaire aimed to identify the nature and extent of potential obstacles in the current international legal framework to the introduction to (wholly or partly) unmanned ships. The questionnaire can be summarized into the following legal issues.
- The legal definition and registration of the remote control ship and autonomous ship
The definition of remote control or autonomous ship is based on the purpose of each individual convention. Current international conventions regulating ships do not generally contain recognized definition of the “Ship” and “Vessel”.
However, due to its geographical feature, countries tend to have different safety requirement for ships; therefore, even the definition of remote control or autonomous ships given by international regulations, may not be accepted by national register of ships.
For example, according to the reply to the questionnaire from Argentina association of maritime law, Argentina Navigation Act prescribes that in order to register a ship in the Argentine Register, regulatory requirements regarding construction and seaworthiness must be fulfilled. However, there are no rules regarding the registration of remote control ships or autonomous ships, as current act are based on the existence of crew on board. The unmanned ships would not be registered by Argentina Registry of ships.
At present, the fragmentation of the definition and registration of ships can affect the deployment and application of remote control ships or autonomous ships. Due to the feature of shipping, which is related to the global transportation network, the definition and registration issue had better be solved at international level by International Maritime Organization (IMO).
- Legal issue of the seafarer
International Convention on Standard of Training Certification and Watchkeeping (STCW) 1978 sets minimum qualification standard for masters, officers and watch personnel on seagoing merchant ships and large yachts.
In the sight of replacing human operator on board with machine, will the convention find no application to remotely controlled or autonomous unmanned ships?
The research of CMI points out the maritime law associations of Finland, Panama and United State assume that the STCW convention would likely apply to shore-based personnel as well in excepted circumstances where there is no new specific legislation. And the British maritime law association states that regardless of whether STCW would apply to unmanned operation or not, it is clear that certain provisions on training and competence would not apply to shore-based controller and other personnel. Japanese maritime association also states that although the convention does not find application to a remotely controlled unmanned ship, certain rules requiring watchkeeping officers to be presented may nevertheless arguably be interpreted to render an unmanned ship in breach of STCW and to that extent be applicable to unmanned ships. Therefore the amendment of convention seems inevitable.
Standing on the other side, the Institute of Marine Engineering Science & Technology recommended that pairing human with machine effectively to enhance human intelligence and performance rather than totally replacing human is an area that should not be overlooked. Even if the application of unmanned ships comes in reality, seafarer skill will still remain an essential component in the long term future of the shipping sector. The minimum qualification of masters, officers and watch personnel may not need to be changed.
Human error has been used to create a blame culture towards the workforce at sea, and it also results from poor implementation/ introduction/ preparation for new technology. Many studies show that seafarers are worried about the impact of autonomous ships. If the development of autonomous ships means replacing all the human elements on ships, people who work in marine sector will not accept those novel technologies easily, and this won’t lead to a safer future of maritime industry.
- Safety requirement of the remote control ship and autonomous ship
Rule 8 (a) and rule 5 of the international regulation for preventing collisions at sea, 1972(COLREGS) require the operation of ships to comply with the duty of “good seamanship”, “proper lookout”.
These rules are based on the operation by human, thus, leading to the following two questions:
(1) Would the operation of unmanned ship contrary to the duty of “good seamanship”?
The duty of good seamanship emphasizes the importance of human experiences and judgments in the operation of a vessel, and the adaptability of responses provided by good seamanship. Whether an autonomous ship would be able to reach this level of adaptive judgment would depend on the sophistication of its autonomous system. According to CMI’s research, the maritime law associations of countries including Argentina, British, Canada, China, German, Japan and Panama emphasize the requirement that autonomous ship must be at least as safe as ships operated by a qualified crew.
(2) Would the proper lookout sets in rule 5 satisfied by camera and aural censoring equipment?
COLREG rule 5 has two vital elements. First, crew on the bridge should pay attention to everything, not just looking ahead out of the bridge windows but looking all around the vessel, using all senses and all personnel equipment. Second, use all information continuously to assess the situation your vessel is in and the risk of collision.
In this context, if the sensors and transmission equipment are sufficient to enable an appraisal of the information received in a similar manner available as if the controller was on board, then Rule 5 should be considered satisfied.
However, it is unlikely that fully autonomous ship could comply with rule 5. It depends on the sophistication of its autonomous system. If the technology is unlikely at present to provide as equivalent spatial awareness and appreciation of the vessel’s positon as there are human on board, then rule 5 would not be considered fulfilled.
- Liability
Liability is an important issue which is frequently mentioned in the area of autonomous ship. According to the study of MUNIN in 2015, liability issue of autonomous ship might arise under the following situations:
(1) Deviation
Suppose a ship was navigating autonomously, and the deviation of the system caused collision damage, how might liability be apportioned between ship-owner and the manufacturers?
According to the research of CMI, 10 maritime law associations stated that under its domestic law, the third party may have a claim against the manufactures. (British, Canada, China, Croatia, Dutch, French, Germany, Italy, Spain, Malta) They may do so in tort if negligence on the part of manufacturers can be proved and if this can be shown to be causative of the damage. In European Union, third parties may also claim under Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member State concerning liability for defective products.
(2) Limitation of liability
Article 1 of the 1976 convention on limitation of liability of owner of ships provides that ship-owner may limit their liability to all claims arising from any incident. The size of limitation is based upon the tonnage of the ship. Within the convention, the term ship-owner is held to include the ship’s owner, charterer, manager or operator.
International conventions dealing with limitation of liability are phrased in neutral terms with regard to the presence of a master or crew; therefore, circumstances in which a ship has no person on board do not appear to undermine the operation of those conventions.
(3) Bill of lading
Bill of lading is a written document signed on behalf of the owner of ship in which goods are embarked, and the ship-owner acknowledges the receipt of the goods, and undertakes to deliver them at the end of voyage. Typically, the shipper will sign the bill of lading along with the owner of the cargo at the point that shipper takes carriage of the cargo in question. The bill of the lading will then be signed by the cargo’s recipient once it has reached its destination. In other words, the document accompanies the cargo all the time, and is signed by the owner, shipper and recipient. It will generally describe the nature and quantity of goods being shipped.
A question arises as in the absence of a master or any crew on board the ship, how will the bill of lading be signed by ship’s master?
III. Conclusion
The shipping industry is a rich, highly complex and diverse industry, which has a history of both triumph and tragedy in its adoption of technology. In light of the potential for the remote and autonomous ship, and for the sake of contributing to the assurance of safe and efficient operation, it is better to understand the impact on the industry. The taxonomy of automation between human and machine is vast and complex, especially in the sector of law.
Therefore, before the system can reach fully autonomy and undertake independent, our law should be ready.
IV. Reference
[1] Comité Maritime International, Maritime Law for Umanned Ships, 2017, available at https://comitemaritime.org/work/unmanned-ships/ (last visited Dec. 25, 2018)
[2] MUNIN, D9.3: Quantitative Assessment, Oct. 10, 2015, available at http://www.unmanned-ship.org/munin/news-information/downloads-information-material/munin-papers/ (last visited Dec. 25, 2018)
[3] Martime Digitalisation & Communication, MSC 100 set to review MASS regulations, Oct. 23, 2018, available at https://www.marinemec.com/news/view,msc-100-set-to-review-mass-regulations_55609.htm (last visited Dec. 25, 2018)
[4] IMAREST, Autonomous Shipping-Putting the human back in the headline, April. 2018, available at https://www.imarest.org/policy-news/institute-news/item/4446-imarest-releases-report-on-the-human-impact-of-autonomous-ships (last visited Dec. 25, 2018)
[5] Danish Martime Authority, Analysis of regulatory barriers to the use of autonomous ships(Final Report), Dec. 2017, available at https://www.dma.dk/Documents/Publikationer/Analysis%20of%20Regulatory%20Barriers%20to%20the%20Use%20of%20Autonomous%20Ships.pdf (last visited Dec. 25, 2018)
Yu, He-Chien
Legal Researcher
A Brief Introduction to Taiwan’s Legislations to Promote Industrial Innovations of the Digital Economy 2023/05/15 I. Background To encourage the development of digital industries in communications, information, cybersecurity, networking and communication, to centralize digital governance and digital infrastructure development and to assist in digital transformation of public and private sectors in Taiwan, the Ministry of Digital Affairs (“the MODA”) was created on August 27, 2022 to spearhead the national digital development policy, communications and digital resources; the development of digital technology use cases and the environment for innovations and talents; policies and regulations governing digital economy industries, national cybersecurity, the government’s digital services, open data and data governance, digital infrastructure, international exchange and cooperation and competence standards for the government’s professional personnel in IT and informational security. The Administration for Digital Industries (ADI) and the Administration for Cyber Security (ACS) have been established as the MODA’s subordinate agencies, to address challenges on all fronts in the digital wave. As the central competent authority on the industrial development of the digital economy, the MODA may subsidize, incentify or support innovative activities of digital economy industries in accordance with Paragraph 1, Article 9 of the Statute for Industrial Innovation and determine relevant matters in accordance with Paragraph 2 of the same article. Hence, the MODA promulgated the Subsidy, Reward and Assistance Regulations for Promoting Industry Innovation (“the Regulations”) on December 23, 2022, to encourage innovation and R&D on software, services, integration and application in telecommunications, information, cybersecurity, networking, and communication. The purpose is to enhance the industry environment and to boost the industry competitiveness. These Regulations serve as the MODA’s flagship efforts in promotion of industrial innovations and highlights Taiwan’s emphasis on digital economy industries. Below is a summary of the Regulations. II. Scope As stated in the overview described in Article 2, the Regulations aim to assist in the development of software products, digital services and infrastructure, system integration and vertical use cases in telecommunications, information, cybersecurity, networking and communication, so as to encourage innovations in digital economy industries such as ecommerce, digital contents, new types of digital services, communications and network deployment, to improve the industry environment and enhance the industry competitiveness. In sum, the “digital economy industries” mentioned in the Regulations refer to software, digital services or digital infrastructure sectors in telecommunications, information, cybersecurity, networking and communication. III. Policy measures According to Paragraph 1, Article 3 of the Regulations, the MODA or its subordinate agencies may provide subsidies, rewards and assistance to the activities in digital economy industries such as promotion of innovation or R&D, supply of technologies and support in upgrade. This may involve the encouragement of creation of innovation of R&D centers by companies; assistance to establishment of innovation or R&D institutions; fostering of cooperation among industries, academia and research organizations; promotion of corporate engagement in talent development at schools and development of human resources in industries; support to innovations by local industries; advocacy of corporate use of big data and the government’s open data; enhancement of communications network resilience and network infrastructure prevalence and other relevant matters. Moreover, the Regulations provide details of the policy measures for subsidies, rewards and support as follows: 1. Subsidies The relevant details are provided from Article 4 to Article 17 of the Regulations. (1) Eligibility According to Paragraph 1, Article 4 of the Regulations, subsidy recipients in principle shall be engaged in activities of digital economy industries, shall be either a sole proprietorship, partnership, limited partnership, or corporation registered in accordance with domestic laws or a natural person who is national of the R.O.C., a natural person from Hong Kong or Macau or a foreign national with permanent residency and has never been listed as a refusal account by any bank. Flexibility can be granted in accordance with Paragraph 2 of the same article. If required for the development of digital economy industries, the MODA or its subordinate agencies may establish separate eligibility criteria for subsidy recipients. However, such eligibility criteria only take effect via public announcement and publication on the Executive Yuan Gazette. Finally, according to Article 13 of the Regulations, no subsidy application may be submitted in event of violation of laws related to environmental protection, labor safety and health or food safety and hygiene during the most recent three years, as determined to be serious by central competent authority. (2) Subsidy limits According to Article 5 of the Regulations, different programs come with different ceilings measured in percentage. In principle, the subsidized amount shall not exceed 50% of the program budget if it is for promotion of industry innovation or R&D or encouragement of corporate use of big data and the government’s open data to develop and innovate commercial applications or service models. However, this does not apply to specific policy considerations or subsidy schemes above the budget and approved by the MODA or its subordinate agencies. For example, the subsidized amount shall not exceed 50% of the course fees for corporate engagement in talent development on campus or enhancement of talent resources for industries. However, this limit does not apply to subsidies to indigenous people, persons with disabilities, low-income households, or the special circumstances approved by the MODA or its subordinate agencies. Support schemes such as assistance to industrial technology and upgrade; encouragement of creation of innovation of R&D centers by companies; assistance to establishment of innovation or R&D institutions; fostering of cooperation among industries, academia and research organizations; support to innovations by local industries; enhancement of communications network resilience and network infrastructure prevalence and other projects shall be announced by the MODA or its subordinate agencies and published on the Executive Yuan Gazette. (3) Subsidy programs According to Articles 6 of the Regulations, there are no specific restrictions on subsidy categories, with two exceptions: (1) promotion of industry innovation or R&D – Subsidies are limited to six categories, i.e., innovation or R&D personnel expenses for approved projects; costs for consumables and raw materials; access and maintenance expenses for innovative or R&D equipment; introduction of intangible assets; commissioning and verification fees of research; and travel expenses. (2) advocacy of corporate use of big data and the government’s open data to develop and innovate commercial applications or service models or enhancement of communications network resilience and network infrastructure prevalence - Subsidies are limited to three categories, i.e., fees for commissioned services; training & education fees; and promotional campaign expenses. (4) Application submission According to Article 7 of the Regulations, an applicant should submit the application form, the project plan and relevant data to the MODA or its subordinate agencies. If the contents of the project plan or documents fail to meet requirements, the MODA or its subordinate agencies may request missing materials before a deadline of up to one month. The MODA or its subordinate agencies may not accept applications without missing materials supplied before deadlines. (5) Acceptance and review According to Article 8 of the Regulations, the MODA or its subordinate agencies shall convene review meetings to review applications, changes and irregularities in the execution of subsidy programs. Applicants may be asked to provide explanations or Personnel may be sent to conduct on-site inspections. If necessary, relevant authorities or institutions may be commissioned assist in financial reviews. Additionally, according to Article 9 of the Regulations, the period from document readiness by an applicant to notification of the completed review to the applicant may not exceed three months. This may be extended by one month if necessary. Finally, according to Article 17 of the Regulations, subsidized projects, subsidy recipients, approval dates, subsidized amounts (including cumulative amounts) and relevant information shall be announced on the websites of the MODA or its subordinate agencies each quarterly unless the disclosure should be restricted or is not provided according to Article 18 of the Freedom of Government Information Law. (6) Contract signing Once reviewed and approved, the applicant must sign the subsidy contract with the MODA or its subordinate agencies within the time period specified by Article 10 of the Regulations. Unless extension has been agreed by the MODA or its subordinate agencies, the approval of the application loses validity if a contract is not signed before the deadline. (7) Matters of adherence by subsidy recipients Once the subsidy contract has been signed, an applicant becomes a subsidy recipient under the Regulations and must abide by relevant terms and conditions. First, the recipient shall establish a separate account for subsidy funds and maintain a separate account book, according to Article 11 of the Regulations. All of the interest generated from the subsidy account and any balance remaining after the project completion shall be fully returned to the national treasury via the MODA or its subordinate agencies. Meanwhile, to examine whether there are any duplications of application, the use of subsidy funds and the effectiveness of project implementation, the MODA or its subordinate agencies may dispatch personnel or commission a fair and just organization to inspect the relevant documents, account books and status of project execution. The subsidy recipient shall not refuse such an examination, is obligated to respond and shall submit work reports and details about the use of funds by following the agreed-upon schedule. In event of breach, the disbursement of subsequent funds may be suspended, under the terms and conditions of the subsidy contract. Second, according to Article 12 of the Regulations, if a recipient fails to execute the subsidized project as planned or the project experiences a significant delay in progress, or there is an overly large gap between the project results and the business plan, or the project fails to pass the review, inspection or acceptance by the MODA or its subordinate agencies and no improvement has been made before the specified deadline, or there is a breach of the Regulations Governing Procurements for Scientific and Technological Research and Development if the subsidized amount exceeds 50% of the recipient’s procurement and it meets the threshold for public announcements under the Government Procurement Act, the MODA or its subordinate agencies may suspend the next disbursement in accordance with the terms and conditions of the subsidy contract, claw back the disbursed subsidy and even stop any subsidy to the recipient for one to five years, depending on the severity of the circumstances. Third, according to Article 14 of the Regulations, the MODA or its subordinate agencies must conduct a comprehensive assessment of effectiveness of subsidized projects and the recipient shall cooperate by providing data required for the assessment. Fourth, according to Article 16 of the Regulations and unless otherwise specified by laws, if the subsidized amount exceeds 50% of the total budget for a technology project, the ownership and utilization of R&D results shall comply with the Government Scientific and Technological Research and Development Results Ownership and Utilization Regulation. In event of breach by the recipient violates, the MODA or its subordinate agencies may terminate the subsidy contract and shall refuse to accept any subsidy application from the recipient for five years from the date of completion of the innovation or R&D. If the reason is attributable to the recipient, the subsidy contract shall be canceled and the subsidies shall be refunded. (8) Subsidy applications According to Article 17 of the Regulations, a subsidy applicant shall declare to the MODA or its subordinate agencies the following: 1) No significant default in the execution of any government-sponsored science and technology projects during the past five years. 2) No suspension currently in force as a result of disciplinary actions in relation to execution of a government-sponsored science and technology project. 3) No tax incentives, rewards or subsidies for the same matter under other laws granted to the same subsidized project. 4) No taxes owed during the past three years. However, individuals who apply for the subsidy under Subparagraph 5 or 6, Paragraph 1, Article 3 are exempted. 5) No violation of laws related to environmental protection, labor safety and health or food safety and hygiene or the People with Disabilities Rights Protection Act during the most recent three years, as determined to be serious by central competent authority. However, this does not apply to circumstances that occurred prior to the enforcement of the Statute. If the applicant refuses to declare the above, the MODA or its subordinate agencies may not accept the application. If any false statement is identified, the application may be rejected, or the subsidy may be withdrawn, the contract may be canceled and the disbursed funds shall be returned. 2. Rewards According to Paragraph 1 of Article 18 of the Regulations, the MODA or its subordinate agencies will announce reward programs for digital economy industries with details on recipients, eligibility criteria, evaluation standards, application procedures, approving agencies and other related matters. Moreover, reward applications are not accepted according to Paragraph 2 of Article 18 and the provisions of Article 13 and Article 15 shall apply mutatis mutandis. Article 17 regarding announcement of government information on subsidy applications shall also apply to reward applications. 3. Assistance Relevant rules are primarily prescribed from Article 19 to Article 21 of the Regulations. (1) Eligibility According to Paragraph 1 of Article 19 of the Regulations, the rules prescribed in Subparagraph 1, Paragraph 1 of Article 4 also apply to the eligibility criteria for assistance to digital economy industries. In other words, assistance recipients in principle shall engage in activities of digital economy industries, either a sole proprietorship, partnership, limited partnership, or corporation registered in accordance with domestic laws or a natural person who is national of the R.O.C., a natural person from Hong Kong or Macau or a foreign national with permanent residency and has never been listed as a refusal account by any bank. Flexibility can be granted outside the aforesaid limitations and in accordance with Paragraph 2 of Article 19. If required for the development of digital economy industries, the MODA or its subordinate agencies may establish separate eligibility criteria for assistance recipients via public announcement and publication on the Executive Yuan Gazette. (2) Oversight of commissioned organizations According to Article 20 of the Regulations, the MODA or its subordinate agencies may evaluate and assess the effectiveness of the assistance services provided by the commissioned organization(s) for recipients as an important basis for reviewing assistance projects. (3) Establishment of a single contact window The assistance unit may establish a single contact window to provide assistance and counseling services, according to Article 21 of the Regulations. 4. General provisions In addition to specific rules, the general provisions prescribed from Article 22 to Article 25 shall apply to subsidies, rewards or assistance provided by the MODA and its subordinate agencies. First, all the funds required for policy measures shall come from the budgets allocated by the MODA or its subordinate agencies, according to Article 25 of the Regulations. Second, the MODA or its subordinate agencies may commission a legal person or a group to handle the application acceptance, review, approval, inspection, subsidy disbursement and claw-back, rewards, assistance and other relevant matters, according to Article 22 of the Regulations. Furthermore, according to Article 23 of the Regulations, the incoming and outgoing of funds for subsidy, reward and assistance projects are managed as follows: 1) The same project applying for subsidies with two or more organizations should list the details of all expenses and the breakdowns and amounts of subsidies, rewards and assistance under application with each government agency. The subsidy, reward and assistance program shall be canceled and the disbursed funds shall be returned in event of concealment or false statements. 2) If the review by each government agency on the use of funds identifies poor results, utilization not consistent with the subsidy purposes, or inflated or dishonest numbers, the subsidy, reward or assistance recipient shall return the disbursed funds. Meanwhile, no subsidy shall be granted to the subsidy, reward or assistance recipient in question for one to five years, depending on the severity of circumstances. 3) If procurement is involved in the subsidy, reward or assistance budget, the subsidy, reward or assistance recipient shall adhere to the Government Procurement Act. 4) When reporting on expenses, the subsidy, reward or assistance recipient shall enumerate in detail the utilization of expenditures and the total amount of spendings. The same project subsidized by two or more organizations shall list the actual sum of subsidies, rewards and assistance. Finally, according to Article 24 of the Regulations, the approval, disbursement and reimbursement of subsidies, rewards and assistance are processed as follows: 1) Disbursement based on project progress: The number of instalments, the method, the amount (percentage) are specified in the contract by the MODA or its subordinate agencies, depending on the project and the timetable. 2) Reimbursement shall be based on the Management Guidelines for the Disposal of Government Expenditure Vouchers, the Matters of Attention Regarding Budget (Donation) Implementations by Central Government Agencies for Private Groups and Individuals and relevant contractual provisions. IV. Conclusions To accelerate the innovation and development of digital economy industries in Taiwan, the MODA has promogulated the Subsidy, Reward and Assistance Regulations for Promoting Industry Innovation in accordance with Paragraph 1, Article 9 of the Statute for Industrial Innovation. It is hoped that the subsidies, rewards and assistance provided by the MODA helps to enhance the competitiveness of digital economy industries and the effectiveness of the digital economy development in addition to the Statute. The Regulations set out detailed rules on policy measures e.g., subsidies, rewards, and assistance. Key matters such as eligible recipients, application procedures, review mechanisms, responsibilities and obligations are clearly defined but certain flexibility is reserved by exceptions. A contract-centric approach provides manoeuvrability in practice specific to project circumstances. It is hoped that the MODA and its subordinate agencies can utilize these Regulations once in force, to enhance the business environment of the digital economy industries and continue to drive industry innovations.
An Introduction to Taiwan’s Regulations Regarding the Security Maintenance and Administration of Personal Information Files in in Digital Economy IndustriesAn Introduction to Taiwan’s Regulations Regarding the Security Maintenance and Administration of Personal Information Files in in Digital Economy Industries 2023/11/29 I. Preface The Personal Data Protection Act (below, the “Act”), Article 27, paragraph 3 authorizes all central government authorities in charge of specific industries to formulate regulations regarding security standards and maintenance plans for their concerned industries. Beginning August 27, 2022, Taiwan transferred authority over information services, software publishers, businesses that do retail sales of goods purely via the Internet, third-party payment providers, and other businesses in digital economy industries from the Ministry of Economic Affairs to the newly-established Ministry of Digital Affairs (MODA). Businesses in the digital economy industries collect, process, and use large amounts of important personal data, and therefore bear a relatively heavy responsibility for maintaining the security of personal data. In light of this, and in accordance with the Act, Article 27, paragraph 3, the MODA therefore promulgated the Regulations Regarding the Security Maintenance and Administration of Personal Information Files in in Digital Economy Industries (below, the “Regulations”) on October 12, 2023. These Regulations specify the standards for digital economy industries’ personal data file security maintenance plans and rules governing the handling of personal data following a business termination (below, “security and maintenance plans”, or “SMPs”). These regulations apply to all businesses in the digital economy industries. In order to reinforce responsibility for personal data security maintenance in the digital economy industries, tiered management is applied to businesses at different scales. The key points of these Regulations are introduced below. II. Where the Regulations apply As stipulated in the Regulations, Article 2, the “digital economy industries” that these Regulations apply to refer to any natural person, private juridical person, or other group, that engages in any of the following business operations: 4871 Retail Sale via Internet (industries that engage in retail sales to others via the Internet, but not including television, radio, phone, or other electronic means, nor postal sales); 582 Software Publishing; 620 Computer Programming, Consultancy and Related Activities; 6312 Data Processing, Hosting and Related Activities (industries that engage in processing customers’ data, server & website hosting, and other related services, but not including online audio/video streaming services); 639 Other Information Service Activities; or 6699 Other Activities Auxiliary to Financial Service Activities Not Elsewhere Classified (third-party payment industries, but not including other fund management activities). For the specific industries covered, see Attachment 1 of the Regulations. III. Security maintenance and management measures The relevant measures are stipulated in Articles 3 to 17 of the Regulations. In consideration that the businesses so regulated may collect, process, or use large amounts of personal data as part of their business activities, they bear a larger responsibility for maintaining the security of personal data than does the average enterprise. In compliance with the Regulations, every such enterprise is required to formulate an SMP, the content of which shall comply with the specifications in Articles 5 to 17. This includes putting in place management personnel and relevant resources; defining and inventorying the scope of personal data; risk assessment; putting internal management procedures in place; and other such matters. These Regulations also adopt tiered management for businesses based on their capital levels, in order to reinforcement the frequency at which security maintenance measures are performed. The specific regulations for security maintenance measures are introduced below. 1. Formulating an SMP In accordance with the Regulations, Article 3, and in order to maintain the security of personal data, each enterprise shall, within three months of the date the Regulations take effect, plan and formulate their SMP. Every enterprise shall also cause all staff members to understand and fully implement the SMP. In order to monitor implementation, the MODA may require that each enterprise submit its implementation of SMP; the enterprise shall then submit their implementation status information in written form within the specified time limit. 2. Making the protection policy known internally In accordance with the Regulations, Article 4, and to make sure that everyone in the enterprise comprehends and implements personal data protection, each enterprise shall make its personal data protection policies known to all personnel within the enterprise. Matters that must be explained include Taiwan’s legal regulations and orders on personal data protection; how personal data may only be collected, processed, and used for specific purposes and in a reasonable, secure way; that protective technology must be at a level of security that could be reasonably expected; points of contact for rights relating to personal data; personal data contingency plans; and proper monitoring of outsourced service providers to whom personal data is outsourced. All of this must be done to make sure that every enterprise carries out their duty for comprehensive, continuous SMP implementation. 3. SMP content (1) Putting in place management personnel with relevant resources In accordance with the Regulations, Article 5; in accordance with both the Regulations as a whole and other laws and orders regarding the protection of personal data; and in order to implement personal data protection, each enterprise shall do the following things: Weigh the size and characteristics of their business to reasonably allocate operating resources; take responsibility for the personal data protection and management policy; and formulate, revise, and implement their SMP. Also, the enterprise’s representative or the representative’s authorized personnel shall carry out formulation and revision, in order to make sure that the SMP’s content is fully carried out. (2) Establishing the scope of personal data In accordance with the Regulations, Article 6, in order to define the scope of personal data to be included in the SMP, each enterprise shall periodically check the status of personal data that is collected, processed, or used. (3) Risk assessment and management mechanisms for personal data In accordance with the Regulations, Article 7, in a timely manner, and in accordance with their already-established personal data scopes and the processes in which their business involves the collection, processing, or use of personal data, each enterprise shall evaluate risks that may arise within their scope and processes. Based on the risk evaluation results, each enterprise shall then adopt appropriate security management and response measures. (4) Incident prevention, reporting, and response mechanisms In accordance with the Regulations, Article 8, and in order to reduce/control damages to data subjects resulting from personal data theft, tampering, damage, destruction, leakage, or other such security incidents, each enterprise shall formulate response, reporting, and prevention mechanisms: 1. Response mechanism: Methods to be followed after a security incident has occurred, to reduce/control damages to data subjects, and appropriate ways to notify data subjects after an incident investigation, as well as what such notifications shall contain. 2. Notification mechanism: Post-incident notifications to data subjects, in a form (such as email, text message, phone call, etc.) that makes it convenient for such subjects to learn what has occurred and what the incident handling status is; also, providing data subjects with a hotline or other way of seeking information later on. 3. Prevention mechanism: A post-incident mechanism for discussing and adjusting the prevention measures. Within 72 hours after an enterprise learns that a personal data security incident has occurred, the enterprise shall use Attachment 2, the Enterprise Personal Data Leak Reporting Form, to notify the MODA of matters such as: A description of what caused the incident; an incident summary; the damage status; possible results from the personal data leakage; proposed response measures; proposed method and time for notifying data subjects; etc. Alternately, the enterprise may notify the special municipality or county/city government to then notify the MODA. If the enterprise is unable to report the incident within the time limit or is unable to supply complete reporting information all at once, the enterprise shall attach explanation of the reasons for the delay, or provide the information in stages. After the MODA or the special municipality or county/city government receives a report, they may implement reasonable handling in accordance with Articles 22 to 25 of the Act. (5) Internal management procedures for personal data collection, processing, and usage In accordance with the Regulations, Article 9, in order to ensure that their collection, processing, and use of personal data complies with the laws and orders regarding the protection of personal data, each enterprise shall do the following: Formulate internal management procedures; assess whether the use, processing, or collection of special categories of personal data are involved; assess data subjects’ consent has been obtained; assess whether the legal circumstances create an exemption from the obligation to inform; etc. The internal management measures shall also include providing data subjects with information on their rights in accordance with the Act, Article 3; putting in place mechanisms for ensuring the accuracy of and inquiring regarding personal data; and periodically reviewing whether the specific purposes for collecting personal data still exist or have expired. (6) Limits, notifications, and monitoring for international transfers In accordance with Article 10 of the Regulations and Article 21 of the Act, when an enterprise’s transfer of personal data across a national border affects data subjects to the extent that there is a major national interests concern, the enterprise shall assess whether MODA restrictions apply to the transfer. The enterprise shall also notify the data subjects of the region(s) that the data is transferred to; perform appropriate monitoring of the data recipient; and provide the data subjects with information on their rights in accordance with the Act, Article 3. (7) Data, personnel, and equipment security management measures 1. Data security management measures: In accordance with the Regulations, Article 11, and when personal data is backup, kept confidential, or transferred by various means based on the risk assessment results, each enterprise shall put in place protective measures against abnormal access behaviors. When an enterprise provides information/communication technology services, the enterprise shall also put in place and regularly monitor intrusion countermeasures, abnormal access monitoring and contingencies, anti-malware mechanisms, account password verification, system testing, and other such data security management measures. 2. Personnel security management measures: In accordance with the Regulations, Article 12, each enterprise shall contractually specify the obligation to maintain confidentiality with all staff members; identify personnel who job duties involve collecting, processing, or using personal data; and periodically assess the appropriateness and necessity of personnel’s permissions to access personal data. 3. Equipment security management measures: In accordance with the Regulations, Article 14, and to prevent personal data being stolen, tampered with, damaged, destroyed, or leaked, each enterprise shall put in place appropriate media protection for personal data storage devices. The protection requirements include management measures such as technology, equipment and secured environments that meet a specific level of security. (8) Education and training In accordance with the Regulations, Article 13, each enterprise shall periodically use education and training to ensure that all staff members understand the following things: The laws and regulations pertaining to personal data protection; their personal duties and roles within their scopes of responsibility; and the requirements for all SMP management procedures, mechanisms, and measures. For any enterprise that engages in retail sales via the Internet, their SMP shall include user training and education regarding personal data protection and management; and the enterprise shall also formulate personal data protection rules for compliance. (9) Continuous audit, recording, and improvement mechanisms 1. Data security auditing mechanisms: In accordance with the Regulations, Article 15, each enterprise shall periodically do internal audits of personal data, then put the audit results into an evaluation report that reviews improvements to the enterprise’s protection policy, SMP, etc. If there are any deficiencies, the enterprise shall make corrections. 2. Use of records, tracking data, and retention of evidence: In accordance with the Regulations, Article 16, and as part of carrying out its SMP, each enterprise shall retain a minimum of five years of records on the collection, processing, and use of personal data; tracking data for automated machinery; and evidence of having implemented the SMP. After an enterprise’s operations cease, it shall retain records of the destruction, transfer, or other deletion of personal data for a minimum of five years. 3. Comprehensive, continuous improvement for personal data security maintenance: In accordance with the Regulations, Article 17, any time an enterprise’s SMP is not implemented, the enterprise shall adopt corrective and preventive measures. Also, based on the SMP’s implementation status, its handling methods/implementation status, developments in data technology, adjustments to the enterprise’s business, and changes in the law and regulations, each enterprise shall periodically review and amend its SMP. 4. Tiered management In accordance with the Regulations, Article 18, and to prevent relatively small businesses having to take on excessive personal data management costs, tiered management is applied. For an enterprise with a specific business scale (having capital of NT$10 million or more, or holding 5,000 or more personal data records), stronger security measure implementation is required, namely, the personal data security measures shall be implemented, reviewed, and improved at least once every twelve months. If an enterprise reaches NT$10 million or more in capital after the Regulations take effect, or if an enterprise’s number of personal data records held reaches 5,000 or more as a result of direct or indirect data collection, then within six months of meeting those conditions, the enterprise shall implement and review the improvement measures at least once every twelve months. 5. Outsourced personal data Commercial outsourcing in the digital economy comes in many forms. In light of this, and in order to make clear each enterprise’s security management obligations with regard to the collection, processing, and use of personal data, Article 19 of the Regulations clearly spells out what duties shall be carried out with regard to any outsourcing that touches on personal data. When an enterprise outsources the collection, processing, or use of personal data, it is considered equivalent to the enterprise’s own activity. Thus, the enterprise shall understand and follow the legal orders and regulations on personal data set by the central government authorities in charge of the outsourcing party’s industries. Any oversight responsibilities arising from outsourcing the collection, processing, or use of others’ personal data shall be clearly stipulated in the outsourcing contract or other such documents. IV. Conclusion The Regulations Regarding the Security Maintenance and Administration of Personal Information Files in in Digital Economy Industries are designed to balance development for Taiwan’s digital economy industries with comprehensive, continuous improvement of personal data security maintenance. In pursuit of those goals, the Regulations clarify what each enterprise must do: Plan, formulate, and carry out security maintenance plans for personal data that falls within the bounds of the enterprise’s business; ensure that all staff members receive training on personal data protection; provide personal data subjects with channels to file complaints and seek consultation on their rights; and inform the government authorities in charge of the digital economy about the enterprise’s SMP, including the status of any personal data security incidents. All this is done in hopes that the security measures will continuously improve the security of personal data in Taiwan’s digital economy industries.
Product Liability of Living Lab ProductsI. Forward Only about 18% of the products or services continue to create good sales and have long product life cycles after entering the stream of commerce. This might denote that mass investing in the R&D does not necessary guarantee to develop popular goods and services. In order to overcome this obstacle, many experts and scholars from different research areas propose different R&D mechanisms to solve this problem. The so called “open innovation” is one of the most dynamic R&D mechanisms in recent years, which is created to compensate the weakness of “closed innovation”. By introducing the concept of “open innovation”, Living Lab invites real users join the projects of un-launched products and services for every possible R&D process to obtain the real interaction wherefrom, to fulfill the goal of “user centric” innovation. However, if users or any third party is injured or damaged from the trial products or services, to what extent Living Labs is liable for is one important question to further future innovation environment. This article will first gives a brief introduction and the development of living labs in Taiwan, follow by applying national laws and analysising obstacles to the liability issue caused by defective Living Lab products. Then, the article will continue to refer to foreign legislation and Living Lab practice, and conclude by suggestions and recommendations to the Living Labs practice in Taiwan. II. Brief Introduction of Living Labs A. Composition of Living Labs The concept of Living Labs was developed by Professor William J. Mitchell from the MIT Media Lab and School of Architecture. Professor Mitchell proposed applying the user-centric research method by using Living Lab as a R&D platform and bring together stockholders (co-creators), including public sectors, companies, universities and research fellows, and the most important, the end-users communities, both professional or non-professionals from various backgrounds, to join the R&D process. B. Operation Mode of Living Labs Living Lab invites end users to join the real world testing either in a digital, physical or virtual environment. Un-launched products or services are provided for testing and users are required to give feedbacks either experience, opinions, suggestions or even ideas to the products or services in return. Living Lab then collets and utilizes the feedbacks and observe the behavior patterns for product or service modification and improvement, future R&D plans and market analysis. C. Benefits of Living Labs Lirving Lab could effectively converse different backgrounds and levels of empirical environment, enhance the efficiency in R&D and bring about different benefits to the stakeholders. By participating in the R&D process, users could give feedbacks to Living Labs to further up the un-launched products and services (on the marketplace) to fit consumers’ needs. For industry, Living Lab provides platforms to get together stakeholders, speed up the integration of stakeholders of different size or from different fields and promote the R&D efficiency. For universities and research institutes, the public-private-people (user)-partnership (PPPP), could further more flexible services or R&D ecosystem and not only to have user-centric innovation, but also user-driven innovation.1 D. Development of Living Labs Living Labs has been energetically developed in Europe. Through the integration of project resources, individual Living Lab forms into Living Labs networks and actively engaging in cross-border or cross-project co-operation. 2 The concept of Living Labs has been introduced into Taiwan, there are several Living Labs in Taiwan so far, for example, Living Labs Taiwan from Institute for Information Industry (III), 3Touch Center (Center for Technology of Ubiquitous Computing and Humanity) from National Cheng Kung University, 4 Insight (Center of Innovation and Synergy for Intelligent Home and Living Technology) from National Taiwan University, 5 and Eco City from National Chiao Tung University. 6 The Living Labs aim to bring about the user-centric and user-driven model and bring new elements to R&D innovation. III. Liability of Losses, Damages, or Injuries Caused by Living Lab Products In order to encourage more end users join the Living Labs experiment, Living Labs usually provide the un-launched products or services as gifts or lend it for free. However, if products or services caused injury, economic loss or property damages to the users or third party during the experiment, to what extent should the Living Lab be liable for. A. Legal Status Upon on discussing of legal liability of Living Labs, the first prong to review is the legal status of Living Labs under the legal system in Taiwan. Although it is called “Lab”, but it is not necessarily to be a lab with “physical facility”, it could also be “virtual Labs”, for example, HP and Firebox are both launch for virtual Living Labs online to invite users join their open innovation projects. The concept of open innovation within the Living Labs environment, where Living Labs play as a role of a cook pot which gather personnel, equipment, and technology from parties from different working fields, integrate resources and creativeness to catalyze innovative ideas for new products and services. Normally, each Living Lab can be viewed as an independent "legal entity". In other words, it can exercise rights ad bear responsibility/liabilities under the law, and therefore, to response to needs for R&D, increase efficiency and contribute matters of legal compliance. B. User’s Legal Claims Against Living Labs 1. Contractual Liability Living Labs often use “user agreements” as legal documents to regulate the legal relationship between Living Labs and users. If there is any injury, damages or losses occurred during the experiment, users can sue Living Labs for breach of contract and sue for liability, warranty or violation of justice of contract. If the product is defective, such as manufacture defect, design defect or lack of proper warning, the injured user can sue Living Labs based on warranty. However under the provisions of Article 411 of the Civil Code, 7 if the product is offered for trial free for charge, if the gift is defective and caused injury, damages or losses to the users, Living Lab is not liable for breach of warranty. Unless the Living Lab intentionally conceal the defects and not information the user, or represent to the user that the product is guaranteed flawlessness and free from defects. Under this situation, Living Lab will be liable for damages caused by the defect. In the situation that when Living Lab only lend the products for trial, with the provisions of Article 466 of the Civil Code, 8 only when Living Lab intentionally conceal the defect, then is liable for the injuries and damages resulting there from. However, the purpose of the Living Labs experiment is to implement the open innovation, through the operation of the mechanism, by inviting potential users to join the experiment and require them to give feedbacks, ideas and recommendations for future product improvement. In addition to that, in most of the situations, it is difficult for Living Labs to foresee the existence of potential risks of their products or intentionally conceal the defects or guarantee the products are without defects; therefore it will be even harder for the injured users to bear the burden to proof the above situations. It is worth to address that, Living Labs and users shall enjoy contract autonomy as long as the provisions and terms of contract are not violating laws, public order and good morals, but not without any restriction. When parties have right of freedom of contract, at the mean time, their contract shall not exceed the boundaries of contractual justice. Especially, the burden and allocation of risks needs to be measured and assessed by the status and interests of the parties on rational bases. Because one of the special characteristics of Living Lab is open to general users to participate the experiment voluntarily, Living Lab usually adapts fill-in standard form contracts for convenience. But for the protection of the users, Living Lab shall pay more attention to the provisions and terms of contract which must not violate Article 247-1 of the Civil Code, 9 for example, provisions of contract shall not waive, decrease or increase liabilities of the parties, waive or limit any party to exercise his/her rights, or significant detriment one another’s’ interests, otherwise that part of the provision shall be void. 2. Tortious Liability When damages are caused by defective Living Lab products, users may be able to sue Living Labs and based his/her causes of action on Consumer Protection Law Article 7 business operator’s liability, 10 The Civil Code Article 191-1 manufacturer’s liability 11 and as well as The Civil Code Article 184 (1) tortious liability. 12 Yet, in order to provide motivations and incentives for users to join the open innovation, Living Labs usually gratuitous lending or gifting products or services to the users, at least in this stage, Living Labs are not conform with the definition of “business operators” 13 in the Consumer Protection Law, in designing, producing, manufacturing, importing or distributing goods, or providing services design, manufacturing, inputs, distribution of goods or the provision of services for business enterprise operators. Nor the Living Labs users are under the same definition of “consumer” 14 protected under the definition of the Consumer Protection Law, as those who enter into transactions, use goods or accept services for the purpose of consumption. Therefore, the relationship between Living Labs and the users are not “consumer relationship” 15 for sale of goods or provision of services, for which the Consumer Protection Law might not be applicable to offer protection to the users. Reviewing from the legislative history, Article 191-1 of the Civil Code was amended after the Consumer Protection Law. The reason for amendment was to maintain the completeness of the torts liability in the Civil Code and in supplement to the inadequacy of the Consumer Protection Law. 16 In referred from the above, the definition of “goods” is synonymous with the definition in the Consumer Protection Law. In order to apply the provisions, parties must be in the “consumer relationship” as regulated in Article 2 (3) of the Consumer Protection Law. As mentioned above, usually, Living Labs provide the products free of use or as gifts, it is really difficult to say there is “consumer relationship” between the parties. The first clause of Article 184 of the Civil Code states, “A person who, intentionally or negligently, has wrongfully damaged the rights of another is bound to compensate him for any injury arising there from. The same rule shall be applied when the injury is done intentionally in a manner against the rules of morals.” Hence, in this situation the burden of proof will lay on the users to prove that Living Labs is either with negligent or intent to damage the users by the defective products. Living Labs adapt open innovation to encourage users to participate into the every possible R&D process and obtain feedbacks or recommendations in return. Therefore, most of the time, Living Labs do not have “intent” to cause damages to the users, but whether Living Labs are with “negligence” will often be difficult to prove by the users. C. Third Party’s Legal Claim Against Living Labs 1. Contractual Liability In the case when a third party, who is not associated with the Living Labs experiment, sustains injury or damage from the defective Living Labs products, he or she might not be able to sue under the terms of contract because there is no contractual relationship exists between the parties. The possible cause of action for the third party might be able to sue Living Labs based on torts liability for damages. 2. Tortious Liability Although Article 7 of the Consumer Protection Law does provide cause of action for the third party to sue against the business operator for defective products, the third party must base his or her claim on the “consumer relationship” between the Living Labs or users. However, as mention as above, the relationship between Living Labs and the users are not under the “consumer relationship” as prescribed in the Consumer Protection Law, thus third party cannot sue Living Labs for damages in accordance with the Consumer Protection Law. As to the application process of provisions prescribed in Article 191-1 and 184 (1) of the Civil Code, the result is as the same as above. IV. Foreign Legislation and Practice A. American Jurisprudence 2d In the Comment of the 63A Am. Jur. 2d Products Liability §1142 states, “[s]trict liability covers not only products which have been sold, but also products that have been designed to be sold, have been produced to be sold, or are offered to be sold or marketed”. Furthermore, introduction into the stream of commerce does not require a transfer of possession; strict liability rests on “foreseeability”, and not on esoteric concepts relating to transfer or delivery of possession. Furthermore, the Comment extends the scope of application of strict liability to the “Transaction Other than Sales”. Strict liability also applies to the distribution products in a commercial transaction other than a sale, one provides the product to another either for use or consumption or as a preliminary step leading to ultimate use or consumption. For products made available for demonstration, testing or trial regulated in 63A Am. Jur. 2d Products Liability §1147, where a product-caused injury has taken place while the product is being tested or used for trial purposes by the prospective buyer, prior to the completion of a sales transaction, the person or entity who placed the product into the stream of commerce by providing it to the prospective buyer may be strictly liable. Strict liability also applies to those who manufacture and supply products to consumers on an investigational basis, even though the "supplying" does not technically amount to a sale. In the Observation of §1147 states that “[a] manufacturer who enters the marketing cycle by way of a demonstration, lease, free sample, or sale is in the best position to know and correct defects in its product, and as between the manufacturer and its prospective consumers, should bear the risk of injury to those prospective consumers when any such defects enter the market uncorrected. In sum, if one sustained injury, damages or economic losses by Living Labs products, he or she may sue Living Labs for product strict liability prescribes in §1142 & §1147. B. Living Labs Practice in Foreign Countries Referring to provisions of “Standard Contract” used between Living Labs and the users in other countries, most of the time, Living Labs might disclaim damages to property, but cannot disclaim legal protection or injury compensation. At the mean time, most of the Living Labs also adapt public safety insurance and product liability insurance to protect themselves and the users. V. Conclusion and Recommendation In conclude, the legal norms in Taiwan seems not be able to offer proper protection to Living Labs and the users. This article suggests that in order to form the ecosystem for the open innovation model of Living Labs, Living Labs shall provide proper protection to the users in order to balance the interests between Living Labs and users and catalyze the motive for the users to join the experiment. In referring to the “Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products” 17 from the Department of Health, besides the proper duty, the main purpose of the guideline is to ensure the safety of the human participants. In the provisions prescribe in Article 22 of the “Good Clinical Guidelines”, the clinical trial agreement or related document shall provide participants with proper compensation or treatment when damage occurs. The “Model Clinical Trail Agreement” also provides provisions of damage compensation and insurance in the template which state the application to the assumption of risks and consumer protection. However, because the pharmaceutical clinical trial is with higher risk, the competent authorities, Department of Health, particularly get involved within the regulations and mechanisms of clinical trials to protect the human participants. In sum, whether the similar mechanism can be applied directly between the Living Labs and users needs for further consideration. Finally, for the continuous operating environment, it is necessary for Living Labs to adapt related laws and measures for the open innovation operating model. It is suggested that Living Labs shall enter contracts in the terms with proper risk allocation in accordance to contract justice and possibly with public safety or product insurance to share their liabilities. 1.EUROPEAN COMMISSION INFORMATION SOCIETY AND MEDIA, Living Labs for User-Driven Open Innovation:An Overview of the Living Labs Methodology, Activities and Achievements, European Commission(2009),at7,availableat http://ec.europa.eu/information_society/activities/livinglabs/docs/brochure_jan09_en.pdf (last accessed on Dec. 31, 2012). 2. Id., at 11-12 & 14. 3.Living Lab Taiwan, http://www.livinglabs.com.tw/index.html (Last accessed Dec. 26, 2012). 4. Touch Center from National Cheng Kung University, http://touch.ncku.edu.tw/touch/?q=node/52 (Last accessed Dec. 26, 2012). 5.Insight from National Taiwan University, http://insight.ntu.edu.tw/zh-tw/node/662 (Last accessed Dec. 26, 2012). 6.Eco City from National Chiao Tung University, http://www.ecocity.org.tw (Last accessed Dec. 26, 2012). 7.Civil Code Article 411, “The donor is not liable for a defect in the thing or right given. But, if he has intentionally concealed the defect or expressly guaranteed that the thing was free from such defect, he is bound to compensate the donee for any injury arising therefrom.” 8.Civil Code Article 466, “If the lender intentionally conceals a defect in the thing lent, he is responsible to the borrower for any injury resulting therefrom.” 9.Civil Code Article 247-1, “If a contract has been constituted according to the provisions which were prepared by one of the parties for contracts of the same kind, the agreements which include the following agreements and are obviously unfair under that circumstance are void. (1) To release or to reduce the responsibility of the party who prepared the entries of the contract. (2) To increase the responsibility of the other party. (3) To make the other party waive his right or to restrict the exercise of his right. (4) Other matters gravely disadvantageous to the other party. 10.Consumer Protection Law Article 7, “ business operators engaging in the design, production or manufacture of goods or in the provisions of services shall ensure that goods and services provided by them meet and comply with the contemporary technical and professional standards of the reasonably expected safety prior to the sold goods launched into the market, or at the time of rendering services. Where goods or services may endanger the lives, bodies, health or properties of consumers, a warning and the methods for emergency handling of such danger shall be labeled at a conspicuous place. Business operators violating the two foregoing two paragraphs and thus causing injury to consumers or third parties shall be jointly and severally liable therefore, provided that if business operators can prove that they are not guilty of negligence, the court may reduce their liability for damages.” 11.Civil Code Article 191-1, “The manufacturer is liable for the injury to another arising from the common use or consumption of his merchandise, unless there is no defectiveness in the production, manufacture, process, or design of the merchandise, or the injury is not caused by the defectiveness, or the manufacturer has exercised reasonable care to prevent the injury. The manufacturer mentioned in the preceding paragraph is the person who produces, manufactures, or processes the merchandise. Those, who attach the merchandise with the service mark, or other characters, signs to the extent enough to show it was produced, manufactured, or processed by them, shall be deemed to be the manufacturer. If the production, manufacture, process, or design of the merchandise is inconsistent with the contents of its manual or advertisement, it is deemed to be defective. The importer shall be as liable for the injury as the manufacturer.” 12.Civil Code Article 184 (1), “A person who, intentionally or negligently, has wrongfully damaged the rights of another is bound to compensate him for any injury arising there from. The same rule shall be applied when the injury is done intentionally in a manner against the rules of morals.” Consumer Protection Law Article 2 (2), “business operators" means those who are engaged in the business of designing, producing, manufacturing, importing or distributing goods, or providing services. Consumer Protection Law Article 2 (1), “consumers" means those who enter into transactions, use goods or accept services for the purpose of consumption. Consumer Protection Law Article 2 (3), “consumer relationship” means the legal relationship arising between consumers and business operators for sale of goods or provision of services. 16.王澤鑑，侵權行為法第二冊：特殊侵權行為，第313-314頁 (出版日期2006年7月) 17.DEPARTMENT OF HEALTH, Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, http://www.6law.idv.tw/6law/law3/%E8%97%A5%E5%93%81%E5%84%AA%E8%89%AF%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97%E6%BA%96%E5%89%87.htm (last visited Dec. 31, 2012)
Japanese Virtual Currency Transaction Law System – with “Payment Services Act” as the CoreIn recent years, because of the uncertainty of the positing of virtual currency under law, the issues of transparency and security etc. arising out in connection therewith are emerging, and the incidents of money-laundering, terrorist attack and investor fraud involving therewith lead to concerns of various countries. Therefore, the new change in Japanese legislations relating to virtual currency exchange service providers falls mainly in the effect of amended contents of “Payment Services Act” and “Act on Prevention of Transfer of Criminal Proceeds”. The reasons for amendment to the legislations are such that virtual currency transaction involves the exchange with statutory currency, and is the outlet/ inlet of the existing financial system; therefore it is necessary to have the virtual currency exchange service providers be supervised[1]. Essential points involving the amendments are stated as follows: 1. Payment Services Act The keys to the amendment to Payment Services Act (hereinafter referred to as the “Act”) are the Act recognizes that virtual currency has the nature of property and inputs the registration system for the exchange service providers, and provides relevant supervisory regulations. (1) Definition of virtual currency As defined in items 1 and 2 of Paragraph 5 of Article 2 of the amended Payment Services Act, virtual currency can be divided into two kinds, but is limited to that which is recorded on an electronic device or any other object by electronic means, and excludes the domestic (Japanese) currency, foreign currency and currency-denominated assets[2]. ① It has 3 elements as follows: It can be used in relation to unspecified persons for the purpose of payment consideration for the purchase or leasing of goods or the receipt of provision of services. It can be purchased from and sold to unspecified persons. Its property value can be transferred by means of an electronic data processing system. ② Its property value can be mutually exchanged with other virtual currency and can be transferred by means of an electronic data processing system. In addition, some authors[3] consider that virtual currency is equivalent to the use of blockchain technology. However, according to the definition after the amendment to laws in Japan, the definition of virtual currency is based the judgment of the above elements rather than the use of blockchain technology. (2) Input of registration system for virtual currency exchange service providers Pursuant to Paragraph 7 of Article 2 of the Payment Services Act, “Exchange Service” is defined as the operation of exchange, agency or management activities. No person may engage in the virtual currency exchange service unless the person is registered[4] with the competent authority (Article 63-2 of the Act). A person who has conducted the virtual currency exchange service without obtaining the registration is subject to imprisonment for not more than three years or a fine of not more than three million yen or both based on Subparagraphs 2, 5 of Article 107 of the Act. (3) Mechanism of users protection: The purpose of the amendment is to take countermeasures for the risks generated from virtual currency exchange, such as pecuniary loss caused by insufficient information, the loss incurred in the custody of users’ property, and disclosure of personal information of users）[5]. Discussions are divided into 4 points. ① Information security management A virtual currency exchange service provider must take necessary measures for information security management (Article 63-8 of the Act) ② Measures for users protection A virtual currency exchange service provider must take relevant protective measures for users, including the provision of explanation for misunderstood transaction and information about contents of transaction (Article 63-10 of the Act) ③ Separate management of property A virtual currency exchange service provider must manage its own property separately from the money or virtual currency of the users, and must retain a certified public accountant or an audit corporation to periodically conduct the external financial audit (Article 63-11 of the Act) ④ Designated Dispute Resolution Organization Referring to financial ADR system, the complaint or dispute matter of users shall be concluded by the Designated Dispute Resolution Organization (Article 63-12 of the Act) (4) Supervision over virtual currency exchange service providers: As regulated by Articles 63-13 ~ 63-20 of the new Payment Services Act, essential contents of supervisory requirements for virtual currency exchange service providers are stated below: ①The obligation to prepare and maintain books and documents ②Annual financial reports ③The authority of the Prime Minister to inspect relevant business ④The Prime Minister orders a virtual exchange service provider to conduct business improvement. ⑤The Prime Minister may revoke the registration of a virtual currency exchange service provider who has obtained the registration through illegal or wrongful means. (5) Penalty for violation of obligations The existing penalties under articles 107~109 and articles 112~117 of the Payment Services Act also apply to virtual currency exchange service providers. The causes of violation of obligations and corresponding penalties are summarized as follows: ① Any person who has not obtained registration or has obtained registration through wrongful means or by use of other’s name is subject to imprisonment for not more than three years or a fine of not more than three million yen, or both (Article 107 of the Act) ② An exchange service provider who has violated the separate management of property or has violated the disposition of suspension of operation is subject to imprisonment for not more than two years or a fine of not more than three million yen, or both (Article 108 of the Act). ③ Any person who has failed to prepare or has falsely prepared books, reports, attachment and documents or has refused to answer the questions or has refused to accept or has hindered the business inspection is subject to imprisonment for not more than one years or a fine of not more than three million yen, or both (Article 109 of the Act) ④ A person who fails to take necessary measure for improving its operation is subject to a fine of not more than one million yen. 2. Act on Prevention of Transfer of Criminal Proceeds In order to prevent from money-laundering, the legitimacy of fund sources must be assured. The amended “Act on Prevention of Transfer of Criminal Proceeds” (hereinafter referred to as the “Act”) incorporates the virtual currency exchange service providers as “specified business operators” and imposes them with the following main obligations: (1) The obligation to confirm user identification (Article 4 of the Act) (2) The obligation to confirm and preserve transaction records (Articles 6 & 7 of the Act) (3) The obligation to report suspicious transactions (Article 11 of the Act) The above are major contents of the amendments to legislations in relation to virtual currency exchange service providers in Japan. The purposes of the amendment are to promote the innovation of virtual currency operators and the balanced development with consumer protection. Therefore, they are included in the Payment Services Act and are subject to similar supervision as with electronic bill and Funds Transfer Service[6]. The reorganization of virtual currency system in Japan has stepped forward. However, the application of actual operation needs continual follow-up and observation, so as to be used as reference for the relevant law system of our country. [1]Financial System Council, The Working Group on Payments and Transaction Banking of the Financial System Council, P27. [2]Currency-Denominated Assets, Assets denominated in currency refers to the “Currency-Denominated Assets” in Japanese and defined in the Payment Services Act: as used in this Act means assets which are denominated in the Japanese currency or a foreign currency, or for which performance of obligations, refund, or anything equivalent thereto (hereinafter referred to as "performance of obligations, etc." in this paragraph) is supposed to be made in the Japanese currency or a foreign currency. In this case, assets for which performance of obligations, etc. is supposed to be made by means of Currency-Denominated Assets are deemed to be Currency-Denominated Assets. [3] ＜Improvement System of Virtual Currency＞, Daiwa Institute of Research, see website:, http://www.dir.co.jp/research/report/law-research/financial/20160520_010904.pdf#search=%27%E4%BB%AE%E6%83%B3%E9%80%9A%E8%B2%A8+%E8%B3%87%E9%87%91%E6%B1%BA%E6%B8%88%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E6%B3%95%E5%BE%8B+%E3%83%96%E3%83%AD%E3%83%83%E3%82%AF%E3%83%81%E3%82%A7%E3%83%BC%E3%83%B3%27 (Ｌast browse date: 12/07/2017) [4]Article 63-2 of the Payment Service Act provides the registration with the Prime Minister; however, in practical operation, the operators shall apply for registration with the local financial bureau. [5]Financial System Council, The Working Group on Payments and Transaction Banking of the Financial System Council, P29. [6]In the Payment Services Act of Japan, it is specified that the remittance business engaged by a non-banking provider was officially named as “Funds Transfer Service”, in which business contents aim at the third payment works. Financial Research Development Funds Management Committee, “Study of the industrial development and management between international non-financial institution payment services”, written by Kuo Chen-Chung and Hsu Shih-Chin, pp60~61(2015).
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