Taiwan Announced the Biobanks Regulations and Management Practices

Taiwan Has Passed “Statute of Human Biobank Management” to Maintain Privacy and Improve Medicine Industries

Due to lack of regulations, divergent opinions abounded about the establishment of Biobanks and collection of human biological specimen. For example, a researcher in an academic research organization and a hospital-based physician collected biospecimens from native Taiwanese. Although they insisted that the collections were for research only, human rights groups, ethics researchers, and groups for natives´ benefits condemned the collections as an invasion of human rights. Consequently, the Taiwanese government recognized the need for Biobanks regulation.

To investigate the relationship between disease and multiple factors and to proceed with possible prevention, The Legislative Yuan Social Welfare and Healthy Environment Committee has passed "the draft statute of human biobank management" through primary reviewing process on December 30, 2009 and subsequently passed through entire three-reading procedure on January 7, 2010. Therefore, the medical and research institute not only can set up optimal gene database for particular disease curing, but also can collect blood sample for database establishment, legally. However, the use of sample collections will be excluded from the use of judiciary purpose.

In the light of to establish large scale biobank is going to face the fundamental human right issue, from the viewpoint of biobank management, it is essential not only to set up the strict ethics regulation for operational standard, but also to make the legal environment more complete. For instance, the Department of Health, Executive Yuan had committed the earlier planning of Taiwan biobank establishment to the Academic Sinica in 2006, and planned to collect bio-specimen by recruiting volunteers. However, it has been criticized by all circles that it might be considered violating the Constitution article 8 provision 1 front paragraph, and article 22 rules; moreover, it might also infringe the personal liberty or body information privacy. Therefore, the Executive Yuan has passed the draft statute of human biobank management which was drafted and reviewed by Department of Health during the 3152nd meeting, on July 16, 2009, to achieve the goal of protecting our nation’s privacy and promoting the development of medical science by management biomedical research affairs in more effective ways. Currently, the draft statute has been passed through the primary review procedure by the Legislative Yuan.

About the draft statute, there are several important points as following: (1) Sample Definition: Types of collected sample include human somatic cell, tissues, body fluids, or other derivatives; (2) Biobank Establishment: It requires not only to be qualified and permitted, but also to set up the ethical reviewing mechanism to strengthen its management and application; (3)Sample Collection and Participant Protection: In accordance with the draft statute, bio-specimen collecting should respect the living ethics during the time and refer to the "Medical Law" article 64 provision 1; before sample collection, all related points of attention should be kept in written form , the participant should be notified accordingly, and samples can only be collected with the participant’s consent. Furthermore, regarding the restrained read right and setting up participants’ sample process way if there were death or lost of their capacity; (4) Biobank Management: The safety regulation, obligation of active notification, free to retreat, data destruction, confidentiality and obligation, and termination of operation handling are stipulated; and (5) Biobank Application: According to the new draft statute, that the biological data can’t be used for other purposes, for example, the use of inquisition result for the "Civil law", article 1063, provision 2, prosecution for denying the parent-child relationship law suit", or according to the "Criminal law", article 213, provision 6. This rule not only protects the participants’ body information and their privacy right, but also clearly defines application limits, as well as to set up the mechanism for inner control and avoid conflict of interests to prevent unnecessary disputes.

Finally, the Department of Health noted that, as many medical researches has shown that the occurrence of diseases are mostly co-effected by various factors such as multiple genes and their living environment, rather than one single gene, developed countries have actively devoted to human biological sample collection for their national biobank establishment. The construction and usage of a large-scale human bank may bring up the critical issue such as privacy protection and ethical problems; however, to meet the equilibrium biomedical research promotion and citizen privacy issue will highly depend on the cooperation and trust between the public and private sectors.

Taiwan Department of Health Announced the Human Biobanks Information Security Regulation

The field of human biobanks will be governed by the Act of Human Biobanks (“Biobanks Act”) after its promulgation on February 3, 2010 in Taiwan. According to Article 13 of the Biobanks Act, a biobank owner should establish its directive rules based on the regulation of information security of biobanks announced by the competent authority. Thus the Department of Health announced the draft of the Human Biobanks Information Security Regulation (“Regulation”) for the due process requirement.

According to the Biobanks Act, only the government institutes, medical institutes, academic institutes, and research institutes are competent to establish biobanks (Article 4). In terms of the collecting of organisms, the participants should be informed of the relevant matters by reasonable patterns, and the collecting of organisms may be conducted after obtaining the written consent of the participants (Article 6). The relative information including the organisms and its derivatives are not allowed to be used except for biological and medical research. After all the protection of biobanks relative information above, the most important thing is the safety regulations and directive rules of the database administration lest all the restrictions of biobanks owners and the use be in vain.

The draft Regulation aims to strengthen the safety of biobanks database and assure the data, the systems, the equipments, and the web circumstances are safe for the sake of the participants’ rights. The significant aspects of the draft are described as below. At first, the regulation should refer to the ISO27001, ISO27002 and other official rules. Concerning the personnel management, the security assessment is required and the database management personnel and researchers may not serve concurrently. In case some tasks are outsourced, the contractor should be responsible for the information security; the nondisclosure agreement and auditing mechanism are required. The application system should update periodically including the anti-virus and firewall programs. The biobanks database should be separated physically form internet connection, including the prohibition of information transforming by email or any other patterns through internet. The authorizing protocol of access to the biobanks should be established and all log files should be preserved in a period. The system establishment and maintenance should avoid remote control. In case the database system is physically out of the owner’s control, the authorization of the officer in charge is required. If an information security accident occurred, the bionbanks owner should contact the competent authority immediately and inform the participants by adequate tunnel. The biobanks owner should establish annual security auditing program and the project auditing will be conducted subject to the necessity. To sum up, while the biobanks database security regulation is fully established, the biobanks owners will have the sufficient guidance in connection with the biobank information security to comply with in the future.

※Taiwan Announced the Biobanks Regulations and Management Practices,STLI, https://stli.iii.org.tw/en/article-detail.aspx?no=105&tp=2&i=168&d=6133 (Date:2020/11/28)
Quote this paper
You may be interested
Executive Yuan roll-out The Policy of “The Free Economic Pilot Zones”

Executive Yuan roll-out The Policy of “The Free Economic Pilot Zones”1.Executive Yuan approved a Bill titled “The Free Economic Pilot Zones Special Act”The “Free Economic Demonstration Zones” (hereinafter as FEDZs) is a critical part to improve the liberalization and internationalization of the economy of Republic of China (R.O.C). By deregulation, FEDZs was conceived as trial zones. Once the results of the program were promising, it would be expanded to the entire country. In order to engage in the regional economic and trade integration, the Executive Yuan approved a Bill titled “The Free Economic Pilot Zones Special Act” (hereinafter as Bill) on April 26th, 2013.On Mar 6th, 2014, the Joint Economic, Internal Administration , and Finance Committee of the Legislation Yuan (the Congress) discussed the Bill for reports and questions. By the end of the March, 2014, the Congress will hold five public hearings. Not until the discussion of the Bill item by item and the passage in the Congress, the second stage of the FEDZ program would not be initiated. There are five main points, including the treatments on foreigners and people from mainland China, tax incentives for Taiwanese businessman, foreign professionals and foreign companies, regulations on untaxed goods and labor, regulations on industrial development, such as the agriculture and the medical, and certain new items on education and professional services.For the reason that the government considered the need of human resources to sustain the operation of the industries, the Executive Yuan is trying to promote innovative education in FEPZs. Since the education requirements for both of public and private universities are unified in local, colleges and universities were restrained and missed some great opportunities to discover their own niches in education. Hence, innovative education in FEPZs is trying to help higher education system to introduce foreign education resources and foresight concepts, and to attract more international students. The innovative educational projects within FEPZs will also facilitate the cooperations among domestic and foreign universities, and set up experimental branch campuses, colleges, degree programs or professional courses. Besides, the financial service sector is also included. Since FEDZs is an important pusher for R.O.C to move forward in regional economic integration, accordingly, the most significant liberate item for the financial industry in the FEPZs is to allow offshore banking units and offshore security units to provide financial products and service (e.g. OSU and OBU). Meanwhile, the financial industry is predicted to receive an NTD$140 billion or more in revenues over the next five year.In summary, FEPZs is regarded as a engine propelling liberalization and internationalization. To gain the international competitiveness, the government will continue to promote policies and measures. By establishing the free economic demonstration zone, it is expected to create innovative effects into the education system and to create more job opportunities.2.Legislation Yuan has reviewd “The Free Ecomonic Pilot Zones Special Act”The Republic of China (R.O.C) have been carried out “free economic” recent years, by promoting “Free Economic Pilot Zone” (hereinafter as FEPZs) to encourage every industrial and foreign investment. Besides, FEPZs will not only keep talents and technologies in R.O.C but also liberalize and internationalize our economic.The Executive Yuan had approved a Bill titled “The Free Economic Pilot Zones Special Act” (hereinafter as the Bill) on Dec. 26th, 2013. At the end of May, the Joint Economic, Internal Administration, and Finance Committee of the Legislation Yuan (the Congress) have taken five public hearings for the Bill, and amended the Bill according to the advices proposed by specialists. Not until the deliberation of the Bill item by item and its passage in the Congress, the second stage of the FEDZ program would not be initiated. There are five main points, including the treatments on foreigners, tax incentives for R.O.C businessman, foreign professionals and foreign companies, regulations on untaxed goods and labor, regulations on industrial development, such as the agriculture and the medical service, and certain new items on education and professional services.The government considers that there have to be enough human resource to sustain the opened industries, so Executive Yuan is trying to promote innovative education in FEPZs. The core concept of FEPZs is foresight, liberalization and internationalization, the premier said, and the higher education systems belong to high-end service and have much more marketability and variability compared to other education systems. Through innovative and efficient way to manage the school could let University being much more liberalized. Furthermore, the higher education systems in R.O.C. have to connect with international education to avoid being marginalized. Our first stage of education innovation will promote to set up “degree programs” and “professional courses”. The first phase for the Ministry of Education is going to found “degree programs” or “professional courses” through collaboration way. The Ministry of Education will also draw up related regulations or guidance on standards for school cooperation, co-regulation, setup conditions, supervision, enrolling new student, and recruiting staff.? Once the Bills pass, The Ministry of Education plans to establish “branch school” and “independence campus” helping R.O.C. higher education goes internationalized.On the other hand, Our medical service also has strong international competitiveness. R.O.C is engage in developing international medical and health industry. The premier said, the Ministry of Health and Welfare have proposed some measures, such as limitation to the number of medical centre, medical personnel working hours, and NHI is not allow to use in the zones.The premier added, on the extemporaneous sittings, “The Free Economic Pilot Zones Special Act” will be the priority bills and be deliberated in the end of June By establishing the free economic demonstration zone, it is expected to propel R.O.C take part in Trans-Pacific Partnership (TPP) and the Regional Comprehensive Economic Partnership (RCEP).3.Executive Yuan’s rapid roll-out of “The Free Economic Pilot Zones”, and has published a report concerning the legal and economic implications of its the BillThe “Free Economic Pilot Zones” (hereinafter as FEPZs) plays a pivotal role in promoting market liberalization, especially at an international level. Premier of the Executive Yuan, Mr. Jiang Yi-Hua has stated that the “market economy” and “innovation economy” allows for tremendous economic prosperity to be embraced by the Republic of China (hereinafter as R.O.C). The seizing of such opportunity has been the goal of government efforts, which can be attested by the recent proposal of the “The Free Economic Pilot Zones Special Act” (hereinafter as the Bill), currently undergoing review and consultation proceedings. The Premier further stressed that the national economy should not be left excluded from international commerce, on the other hand, it is imperative that closer economic bonds with other nations are forged, therefore allowing itself open up to wider scope of opportunities for growth. The key in rendering this possible is through the enactment of laws. At a time, when Trans-Pacific nations, including the United States of America, Japan and countries from Southeast Asia, are working towards regional economic cooperation, if R.O.C. is to be left out, it is feared that its position in the global market would further be marginalized.The core innovative strengths of the FEPZs include “Smart Logistics”, “International healthcare services”, “Value added agriculture”, “Financial Services”, “Education Innovation”, all of which are implemented by employing R.O.C.’s finest workforce, knowledge, information and communications technology (ICT), geographical position and cross-strait relationship advantages, leading way for an advantageous basis for pioneering economic development. The first stage of development will be based on 6 locations proximal to the sea (including Keelung Port, Taipei Port, Kaohsiung Port, Suao Harbor, Anping Port, Taichung Port) and Taoyuan Aerotropolis and Pingtung Agricultural Biotech Park. The second stage of development would only commence after the Bill have been approved by the legislative Yuan, which would attract much capital investment, hence boosting high employment rates. Presently, besides the aforementioned regions opened up for the FEPZs, other cities and industrial sites (including those from offshore islands), are striving to gain membership of the FEPZs, or applying for empirical research of the FEPZs.The Executive Yuan has published a report concerning the legal and economic implications of its the Bill on May 2014. The report largely consists of assessments made by varying governing bodies, such as Ministry of Home Affairs, Financial Supervisory Commission etc., on the implications of the draft concerning real estate, employment, fiscal income, logistics, conditions for medical care, agriculture, higher education, social environment and social wealth redistribution etc.Furthermore, international attention has been closely centered on the progress of FEPZs. During the “The third review of the trade policies and practices of Chinese Taipei” after R.O.C accession to the World Trade Organization (WTO) held on the 17th of September 2014 in Geneva, each member state has demonstrated expectations arising out of the direction and planning undertaken for the FEPZs. National economic and international commercial reforms are under way and have seen much progress in further promoting the overall strength of the economic system, in an effort to respond to the rapid global political and economic developments, for example, through the signing of Economic Cooperation Framework Agreement (ECFA), and the implementation of FEPZs policies. In the future, it will be expected that R.O.C. will strive for a more integral international commercial system, allowing much capital investment inflows as well as the cultivating of high-caliber human resources.To promote more liberal and internationalized development of Taiwan economy, government of Republic of China (R.O.C) approved the “Free Economic Pilot Zone (FEPZ) Plan,” which the Bill is currently censored in Legislation Yuan and the measures would be implemented in two phases. The first phase of FEPZs would be initiated within six free trade ports, Taoyuan airport free trade zone, and Pingtung Agricultural Biotechnology Park; other industries that match up with the idea of liberalization, internationalization and foresight can all be incorporated into FEPZ through continuing examination under Execution Yuan. After this special legislation is passed, the set-ups of demonstration zones can be applied by authorities either of central or of local government and the related promotion works of the second phase will be unfolded immediately.Heading to the target of becoming Kin-Xiao (Kinmen and Xiaomen) Free Trade Zone, Kinmen government planned to apply to be one of the FEPZs and thus cooperated with Taiwan Institute of Economic Research (TIER) on December 11, for a commissioned research (which was later released on the conference of accelerating Kin-Xia FTZ on December 19) on evaluating if Kinmen is qualified for an application of FEPZs. Kinmen’s critical location and the featured industries have composed a perfect environment complying with the ideas such as value-added agriculture, international healthcare and innovative education for FEPZ. For instance, the white liquor industry in Kinmen represents the international management and promotion of agricultural products, and is the best example for value-added agriculture. “Long-term Healthcare Village in Kinmen,” which is currently developing in Kinmen, would also be a drive for international healthcare industry. Based on the Taiwan-featured culture, “International Education City” could be developed with a liberal and innovative atmosphere, which would attract famous schools in world to set up their branch school in Kinmen. Above all, Kinmen County vice Mayor, Wu Yo-Chin, indicated that Kinmen would be the first choice for FEPZ and would hold the key to open a new gate for the Cross-Strait. The vice Mayor emphasized that Kinmen government has well budgeting and financial management, which needn’t the extra aids from central government, yet Kinmen was excluded in the first phase of FEPZs. Although Kinmen would apply to be a FEPZ in the second phase after the special legislation passed, Kinmen still strived for taking part in the first phase of FEPZs due to the uncertain schedule for implementation of regulations on FEPZs.National Development Council (NDC), however, gave an opinion on issue of Kinmen applying to be in the first phase of FEPZs, which declared again the original plan for the first phase only included six free trade ports, Taoyuan airport free trade zone, and Pingtung Agricultural Biotechnology Park. NDC also suggested Kinmen could still follow after the first phase and apply to be a FEPZ in the second phase.

Research on Policies for building a digital nation in Recent Years (2016-2017)

Research on Policies for building a digital nation in Recent Years (2016-2017)   Recent years, the government has already made some proactive actions, including some policies and initiatives, to enable development in the digital economy and fulfill the vision of Digital Nation. Those actions are as follows: 1. CREATING THE “FOOD CLOUD” FOR FOOD SAFETY CONTROLS   Government agencies have joined forces to create an integrated “food cloud” application that quickly alerts authorities to food safety risks and allows for faster tracing of products and ingredients. The effort to create the cloud was spearheaded by the Executive Yuan’s Office of Food Safety under the leadership of Vice Premier Chang San-cheng on January 12, 2016.   The “food cloud” application links five core systems (registration, tracing, reporting, testing, and inspection) from the Ministry of Health and Welfare (MOHW) with eight systems from the Ministry of Finance, Ministry of Economic Affairs, Ministry of Education (MOE), Council of Agriculture and Environmental Protection Administration.   The application gathers shares and analyzes information in a methodical and systematic manner by employing big data technology. To ensure the data can flow properly across different agencies, the Office of Food Safety came up with several products not intended for human consumption and had the MOHW simulate the flow of those products under import, sale and supply chain distribution scenarios. The interministerial interface successfully analyzed the data and generated lists of food risks to help investigators focus on suspicious companies.   Based on these simulation results, the MOHW on September 2, 2015, established a food and drug intelligence center as a mechanism for managing food safety risks and crises on the national level. The technologies for big data management and mega data analysis will enable authorities to better manage food sources and protect consumer health.   In addition, food cloud systems established by individual government agencies are producing early results. The MOE, for instance, rolled out a school food ingredient registration platform in 2014, and by 2015 had implemented the system across 22 countries and cities at 6,000 schools supplying lunches for 4.5 million students. This platform, which made school lunch ingredients completely transparent, received the 2015 eAsia Award as international recognition for the use of information technology in ensuring food safety. 2. REVISING DIGITAL CONVERGENCE ACTS   On 2016 May 5th, the Executive Yuan Council approved the National Communications Commission's (NCC) proposals, drafts of “Broadcasting Terrestrial and Channel Service Suppliers Administration Act”, “Multichannel Cable Platform Service Administration Act”, “Telecommunications Service Suppliers Act”, “Telecommunications Infrastructure and Resources Administration Act”, “Electronic Communications Act”, also the five digital convergence laws. They will be sent to the Legislature for deliberation. But in the end, this version of five digital convergence bills did not pass by the Legislature.   However, later on, November 16, 2017, The Executive Yuan approved the new drafts of “Digital Communication Act” and the “Telecommunication Service Management Act”.   The “Digital Communication Act” and the “Telecommunication Service Management Act” focused summaries as follows:   1. The digital communication bill   A. Public consultation and participation.   B. The digital communication service provider ought to use internet resource reasonability and reveal network traffic control measures.   C. The digital communication service provider ought to reveal business information and Terms of Service.   D. The responsibility of the digital communication service provider.   2. The telecommunication service management bill   A. The telecommunication service management bill change to use registration system.   B. The general obligation of telecommunications to provide telecommunication service and the special obligation of Specific telecommunications.   C. Investment, giving, receiving and merging rules of the telecommunication service.   Telecommunications are optimism of relaxing rules and regulations, and wish it would infuse new life and energy into the market. Premier Lai instructed the National Communications Commission and other agencies to elucidate the contents of the two communication bills to all sectors of society, and communicate closely with lawmakers of all parties to build support for a quick passage of the bills. 3. FOCUSING ON ICT SECURITY TO BUILD DIGITAL COUNTRIES   The development of ICT has brought convenience to life but often accompanied by the threat of illegal use, especially the crimes with the use of new technologies such as Internet techniques and has gradually become social security worries. Minor impacts may cause inconvenience to life while major impacts may lead to a breakdown of government functions and effects on national security. To enhance the capability of national security protection and to avoid the gap of national security, the Executive Yuan on August 1st 2016 has upgraded the Office of Information and Communication Security into the Agency of Information and Communication Security, a strategic center of R.O.C security work, integrating the mechanism of the whole government governance of information security, through specific responsibility, professionalism, designated persons and permanent organization to establish the security system, together with the relevant provisions of the law so that the country's information and communication security protection mechanism will become more complete. The efforts to the direction could be divided into three parts:   First, strengthening the cooperation of government and private sectors of information security: In a sound basis of legal system, the government plans to strengthen the government and some private sectors’ information security protection abilities ,continue to study and modify the relevant amendments to the relevant provisions, strengthen public-private collaborative mechanism, deepen the training of human resources and enhance the protection of key information infrastructure of our country.   Second, improving the information and communication security professional capability: information and communication security business is divided into policy and technical aspects. While the government takes the responsibility for policy planning and coordination, the technical service lies in an outsourcing way. Based on a sound legal system, the government will establish institutionalized and long-term operation modes and plan appropriate organizational structures through the discussion of experts and scholars from all walks of life.   Third, formulating Information and Communication Safety Management Act and planning of the Fifth National Development Program for Information and Communication Security: The government is now actively promoting the Information and Communication Safety Management Act as the cornerstone for the development of the national digital security and information security industry. The main content of the Act provides that the applicable authorities should set up security protection plan at the core of risk management and the procedures of notification and contingency measures, and accept the relevant administrative check. Besides the vision of the Fifth National Development Program for Information and Communication Security which the government is planning now is to build a safe and reliable digital economy and establish a safe information and communication environment by completing the legal system of information and communication security environment, constructing joint defense system of the national Information and Communication security, pushing up the self-energy of the industries of information security and nurture high-quality human resources for elite talents for information security. 4. THE DIGITAL NATION AND INNOVATIVE ECONOMIC DEVELOPMENT PLAN   The Digital Nation and Innovative Economic Development Plan (2017-2025) known as “DIGI+” plan, approved by the Executive Yuan on November 24, 2016. The plan wants to grow nation’s digital economy to NT $ 6.5 trillion (US$205.9 billion), improve the digital lifestyle services penetration rate to 80 %, increase broadband connections to 2 Gbps, ensure citizens’ basic rights to have 25 Mbps broadband access, and put our nation among the top 10 information technology nations worldwide by 2025.   The plan contains several important development strategies: DIGI+ Infrastructure: Build infrastructure conducive to digital innovation. DIGI+ Talent: Cultivate digital innovation talent. DIGI+ Industry: Support cross-industry transformation through digital innovation. DIGI+ Rights: Make R.O.C. an advanced society that respects digital rights and supports open online communities. DIGI+ Cities: Build smart cities through cooperation among central and local governments and the industrial, academic and research sectors. DIGI+ Globalization: Boost nation’s standing in the global digital service economy.   The plan also highlights few efforts:   First is to enrich “soft” factors and workforce to create an innovative environment for digital development. To construct this environment, the government will construct an innovation-friendly legal framework, cultivate interdisciplinary digital talent, strengthen research and develop advanced digital technologies.   Second is to enhance digital economy development. The government will incentivize innovative applications and optimize the environment for digital commerce.   Third, the government will develop an open application programming interface for government data and create demand-oriented, one-stop smart government cloud services.   Fourth, the government will ensure broadband access for the disadvantaged and citizens of the rural area, implement the participatory process, enhance different kinds of international cooperation, and construct a comprehensive humanitarian legal framework with digital development.   Five is to build a sustainable smart country. The government will use smart network technology to build a better living environment, promote smart urban and rural area connective governance and construction and use on-site research and industries innovation ecosystem to assist local government plan and promote construction of the smart country.   In order to achieve the overall effectiveness of the DIGI + program, interdisciplinary, inter-ministerial, inter-departmental and inter-departmental efforts will be required to collaborate with the newly launched Digital National Innovation Economy (DIGI +) Promotion Team. 5. ARTIFICIAL INTELLIGENCE SCIENTIFIC RESEARCH STRATEGY   The Ministry of Science and Technology (MOST) reported strategy plan for artificial intelligence (AI) scientific research at Cabinet meeting on August 24, 2017. Artificial intelligence is a powerful and inevitable trend, and it will be critical to R.O.C.’s competitiveness for the next 30 years.   The ministry will devote NT$16 billion over the next five years to building an AI innovation ecosystem in R.O.C. According to MOST, the plan will promote five strategies:   1. Creating an AI platform to provide R&D services   MOST will devote NT$5 billion over the next four years to build a platform, integrating the resources, providing a shared high-speed computing environment and nurturing emerging AI industries and applications.   2. Establishing an AI innovative research center   MOST will four artificial intelligence innovation research centers across R.O.C. as part of government efforts to enhance the nation’s competitiveness in AI technology. The centers will support the development of new AI in the realms of financial technology, smart manufacturing, smart healthcare and intelligent transportation systems.   3. Setting up AI robot maker spaces   An NT$2 billion, four-year project assisting industry to develop the hardware-software integration of robots and innovative applications was announced by the Ministry of Science and Technology.   4. Subsidizing a semiconductor “moonshot” program to explore ambitious and groundbreaking smart technologies   This program will invest NT$4 billion from 2018 through 2021 into developing semiconductors and chip systems for edge devices as well as integrating the academic sector’s R&D capabilities and resources. the project encompasses cognitive computing and AI processor chips; next-generation memory designs; process technologies and materials for key components of sensing devices; unmanned vehicles, AR and VR; IoT systems and security.   5. Organizing Formosa Grand Challenge competitions   The program is held in competitions to engage young people in the development of AI applications.   The government hopes to extend R.O.C.’s industrial advantages and bolster the country’s international competitiveness, giving R.O.C. the confidence to usher in the era of AI applications. All of these efforts will weave people, technologies, facilities, and businesses into a broader AI innovation ecosystem. 6. INTELLIGENT TRANSPORTATION SYSTEM PLANS   Ministry of Transportation and Communications (MOTC) launched plans to develop intelligent transportation systems at March 7th in 2017. MOTC integrates transportation and information and communications technology through these plans to improve the convenience and reduce the congestion of the transportation. These plans combine traffic management systems for highways, freeways and urban roads, a multi-lane free-flow electronic toll collection system, bus information system that provides timely integrated traffic information services, and public transportation fare card readers to reduce transport accidence losses, inconvenience of rural area, congestion of main traffic arteries and improve accessibility of public transportation.   There are six plans are included: 1. Intelligent transportation safety plan; 2. Relieve congestion on major traffic arteries; 3. Make transportation more convenient in Eastern Taiwan and remote areas; 4. Integrate and share transportation resources; 5. Develop “internet-of-vehicles” technology applications; and 6. Fundamental R&D for smart transportation technology.   These plans promote research and development of smart vehicles and safety intersections, develop timely bus and traffic information tracking system, build a safe system of shared, safe and green-energy smart system, and subsidize the large vehicles to install the vision enhancement cameras to improve the safety of transportation. These plans also use eTag readers, vehicle sensors and info communication technologies to gather the traffic information and provide timely traffic guidance, reduce the congestion of the traffic flow. These plans try to use demand-responsive transit system with some measures such as combine public transportation and taxi, to improve the flexibility of the public traffic service and help the basic transportation needs of residents in eastern Taiwan and rural areas to be fulfilled. A mobile transport service interface and a platform that integrating booking and payment processes are also expected to be established to provide door-to-door transportation services and to integrate transportation resources. And develop demonstration projects of speed coordination of passenger coach fleets, vehicle-road interaction technology, and self-driving car to investigate and verify the issues in technological, operational, industrial, legal environments of internet-of-vehicles applications in our country. Last but not least, research and development on signal control systems that can be used in both two and four-wheeled vehicles, and deploy an internet-of-vehicles prototype platform and develop drones traffic applications.   These plans are expected to reduce 25% traffic congestion, 20% of motor vehicle incidence, leverage 10% using rate of public transportation, raise 20% public transportation service accessibility of rural area and create NT$30 billion production value. After accomplishing these targets, the government can establish a comprehensive transportation system and guide industry development of relating technology areas.   Through the aforementioned initiatives, programs, and plans, the government wants to construct the robust legal framework and policy environment for digital innovation development, and facilitate the quality of citizens in our society.

Experiences about opening data in private sector

Experiences about opening data in private sector Ⅰ. Introduction   Open data is the idea that data should be available freely for everyone to use and republish without restrictions from copyright, patents or other mechanisms of control. The concept of open data is not new; but a formalized definition is relatively new, and The Open Definition gives full details on the requirements for open data and content as follows:   Availability and access: the data must be available as a whole with no more than a reasonable reproduction cost, preferably by downloading over the internet. The data must also be available in a convenient and modifiable form.   Reuse and redistribution: the data must be provided under terms that permit reuse and redistribution including the intermixing with other datasets. The data shall be machine-readable.   Universal participation: everyone must be able to use, reuse and redistribute the data— which by means there should be no discrimination against fields of endeavor or against persons or groups. For example, “non-commercial” restrictions that would prevent “commercial” use, or restrictions of use for certain purposes are not allowed.   In order to be in tune with international developmental trends, Taiwan passed an executive resolution in favor of promoting Open Government Data in November 2012. Through the release of government data, open data has grown significantly in Taiwan and Taiwan has come out on top among 122 countries and areas in the 2015 and 2016 Global Open Data Index[1].   The result represented a major leap for Taiwan, however, progress is still to be made as most of the data are from the Government, and data from other territories, especially from private sector can rarely be seen. It is a pity that data from private sector has not being properly utilized and true value of such data still need to be revealed. The following research will place emphasis to enhance the value of private data and the strategies of boosting private sector to open their own data. Ⅱ. Why open private data   With the trend of Open Government Data recent years, countries are now starting to realize that Open Government Data is improving transparency, creating opportunities for social and commercial innovation, and opening the door to better engagement with citizens. But open data is not limited to Open Government Data. In fact, the private sector not only interacts with government data, but also produces a massive amount of data, much of which in need of utilized.   According to the G20 open data policy agenda made in 2014, the potential economic value of open data for Australia is up to AUD 64 billion per annum, and the potential value of open data from private sector is around AUD 34 billion per annum. Figure 1 Value of open data for Australia (AUD billion per annum) Source: McKinsey Global Institute   The purpose for opening data held by private entities and corporations is rooted in a broad recognition that private data has the potential to foster much public good. Openness of data for companies can translate into more efficient internal governance frameworks, enhanced feedback from workers and employees, improved traceability of supply chains, accountability to end consumers, and with better service and product delivery. Open Private Data is thus a true win-win for all with benefiting not only the governance but environmental and social gains.   At the same time, a variety of constraints, notably privacy and security, but also proprietary interests and data protectionism on the part of some companies—hold back this potential. Ⅲ. The cases of Open Private Data   Syngenta AG, a global Swiss agribusiness that produces agrochemicals and seeds, has established a solid foundation for reporting on progress that relies on independent data collection and validation, assurance by 3rd party assurance providers, and endorsement from its implementing partners. Through the website, Syngenta AG has shared their datasets for agricultural with efficiency indicators for 3600 farms for selected agro-ecological zones and market segments in 42 countries in Europe, Africa, Latin America, North America and Asia. Such datasets are precious but Syngenta AG share them for free only with a Non-Commercial license which means users may copy and redistribute the material in any medium or format freely but may not use the material for commercial purposes. Figure 2 Description and License for Open data of Syngenta AG Source: http://www.syngenta.com   Tokyo Metro is a rapid transit system in Tokyo, Japan has released information such as train location and delay times for all lines as open data. The company held an Open Data Utilization Competition from 12 September to 17 November, 2014 to promote development of an app using this data and continues to provide the data even after the competition ended. However, many restrictions such as non-commercial use, or app can only be used for Tokyo Metro lines has weakened the efficiency of open data, it is still valued as an initial step of open private data. Figure 3 DM of Tokyo Metro Open data Contest Source: https://developer.tokyometroapp.jp/ Ⅳ. How to enhance Open Private Data   Open Private Data is totally different from Open Government Data since “motivation” is vital for private institutions to release their own data. Unlike the government data can be disclosed and free to use via administrative order or legislation, all of the data controlled by private institutions can only be opened under their own will. The initiative for open data therefore shall focus on how to motivate private sectors releasing their own data-by ensuring profit and minimizing risks.   Originally, open data shall be available freely for everyone to use without any restrictions, and data owners may profit indirectly as users utilizing their data creating apps, etc. but not profit from open data itself. The income is unsteady and data owners therefore lose their interest to open data. As a countermeasure, it is suggested to make data chargeable though this may contradict to the definition of open data. When data owners can charge by usage or by time, the motivation of open data would arise when open data is directly profitable.   Data owners may also worry about many legal issues when releasing their own data. They may not care about whether profitable or not but afraid of being involved into litigation disputes such as intellectual property infringement, unfair competition, etc. It is very important for data owners to have a well protected authorization agreement when releasing data, but not all of them is able to afford the cost of making agreement for each data sharing. Therefore, a standard sample of contract that can be widely adopted plays a very important role for open private data.   A data sharing platform would be a solution to help data owners sharing their own data. It can not only provide a convenient way to collect profit from data sharing but help data owners avoiding legal risks with the platform’s standard agreement. All the data owners have to do is just to transfer their own data to the platform without concern since the platform would handle other affairs. Ⅴ. Conclusion   Actively engaging the private sector in the open data value-chain is considered an innovation imperative as it is highly related to the development of information economy. Although many works still need to be done such as identifying mechanisms for catalyzing private sector engagement, these works can be done by organizations such as the World Bank and the Centre for Open Data Enterprise. Private-public collaboration is also important when it comes to strengthening the global data infrastructure, and the benefits of open data are diverse and range from improved efficiency of public administrations to economic growth in the private sector. However, open private data is not the goal but merely a start for open data revolution. It is to add variation for other organizations and individuals to analyze to create innovations while individuals, private sectors, or government will benefit from that innovation and being encouraged to release much more data to strengthen this data circulation. [1] Global Open Data Index, https://index.okfn.org/place/(Last visited: May 15, 2017)

Israel’s Technological Innovation System

I.Introduction Recently, many countries have attracted by Israel’s technology innovation, and wonder how Israel, resource-deficiency and enemies-around, has the capacity to enrich the environment for innovative startups, innovative R&D and other innovative activities. At the same time, several cross-border enterprises hungers to establish research centers in Israel, and positively recruits Israel high-tech engineers to make more innovative products or researches. However, there is no doubt that Israel is under the spotlight in the era of innovation because of its well-shaped national technology system framework, innovative policies of development and a high level of R&D expenditure, and there must be something to learn from. Also, Taiwanese government has already commenced re-organization lately, how to tightly connect related public technology sectors, and make the cooperation more closely and smoothly, is a critical issue for Taiwanese government to focus on. Consequently, by the observation of Israel’s national technology system framework and technology regulations, Israel’s experience shall be a valuable reference for Taiwanese government to build a better model for public technology sectors for future cooperation. Following harsh international competition, each country around the world is trying to find out the way to improve its ability to upgrade international competitiveness and to put in more power to promote technology innovation skills. Though, while governments are wondering how to strengthen their countries’ superiority, because of the differences on culture and economy, those will influence governments’ points of view to form an appropriate national innovative system, and will come with a different outcome. Israel, as a result of the fact that its short natural resources, recently, its stunning performance on technology innovation system makes others think about whether Israel has any characteristics or advantages to learn from. According to Israeli Central Bureau of Statistics records, Israel’s national expenditures on civilian R&D in 2013 amounted to NIS 44.2 billion, and shared 4.2% of the GDP. Compared to 2012 and 2011, the national expenditure on civilian R&D in 2013, at Israel’s constant price, increased by 1.3%, following an increase of 4.5% in 2012 and of 4.1% in 2011. Owing to a high level of national expenditure poured in, those, directly and indirectly, makes the outputs of Israel’s intellectual property and technology transfer have an eye-catching development and performance. Based on Israeli Central Bureau of Statistics records, in 2012-2013, approximately 1,438 IP invention disclosure reports were submitted by the researchers of various universities and R&D institutions for examination by the commercialization companies. About 1,019 of the reports were by companies at the universities, an increase of 2.2% compared to 2010-2011, and a 1% increase in 2010-2011 compared to 2008-2009. The dominant fields of the original patent applicants were medicines (24%), bio-technology (17%), and medical equipment (13%). The revenues from sales of intellectual property and gross royalties amounted to NIS 1,881 million in 2012, compared to NIS 1,680 million in 2011, and increase of 11.9%. The dominant field of the received revenues was medicines (94%). The revenues from sales of intellectual property and gross royalties in university in 2012 amounted to NIS 1,853 million in 2012, compared to NIS 1,658 million in 2011, an increase of 11.8%. Therefore, by the observation of these records, even though Israel only has 7 million population, compared to other large economies in the world, it is still hard to ignore Israel’s high quality of population and the energy of technical innovation within enterprises. II.The Recent Situation of Israel’s Technology Innovation System A.The Determination of Israel’s Technology Policy The direction and the decision of national technology policy get involved in a country’s economy growth and future technology development. As for a government sector deciding technology policy, it would be different because of each country’s government and administrative system. Compared to other democratic countries, Israel is a cabinet government; the president is the head of the country, but he/she does not have real political power, and is elected by the parliament members in every five years. At the same time, the parliament is re-elected in every four years, and the Israeli prime minister, taking charge of national policies, is elected from the parliament members by the citizens. The decision of Israel’s technology policy is primarily made by the Israeli Ministers Committee for Science and Technology and the Ministry of Science and Technology. The chairman of the Israeli Ministry Committee for Science and Technology is the Minister of Science and Technology, and takes charge of making the guideline of Israel’s national technology development policy and is responsible for coordinating R&D activities in Ministries. The primary function of the Ministry of Science and Technology is to make Israel’s national technology policies and to plan the guideline of national technology development; the scope includes academic research and applied scientific research. In addition, since Israel’s technology R&D was quite dispersed, it means that the Ministries only took responsibilities for their R&D, this phenomenon caused the waste of resources and inefficiency; therefore, Israel government gave a new role and responsibility for the Chief Scientists Forum under the Ministry of Science and Technology in 2000, and wished it can take the responsibility for coordinating R&D between the government’s sectors and non-government enterprises. The determination of technology policy, however, tends to rely on counseling units to provide helpful suggestions to make technology policies more intact. In the system of Israel government, the units playing a role for counseling include National Council for Research and Development (NCRD), the Steering Committee for Scientific Infrastructure, the National Council for Civil Research and Development (MOLMOP), and the Chief Scientists Forums in Ministries. Among the aforementioned units, NCRD and the Steering Committee for Scientific Infrastructure not only provide policy counseling, but also play a role in coordinating R&D among Ministries. NCRD is composed by the Chief Scientists Forums in Ministries, the chairman of Planning and Budgeting Committee, the financial officers, entrepreneurs, senior scientists and the Dean of Israel Academy of Sciences and Humanities. NCRD’s duties include providing suggestions regarding the setup of R&D organizations and related legal system, and advices concerning how to distribute budgets more effectively; making yearly and long-term guidelines for Israel’s R&D activities; suggesting the priority area of R&D; suggesting the formation of necessary basic infrastructures and executing the priority R&D plans; recommending the candidates of the Offices of Chief Scientists in Ministries and government research institutes. As for the Steering Committee for Scientific Infrastructure, the role it plays includes providing advices concerning budgets and the development framework of technology basic infrastructures; providing counsel for Ministries; setting up the priority scientific plans and items, and coordinating activities of R&D between academic institutes and national research committee. At last, as for MOLMOP, it was founded by the Israeli parliament in 2002, and its primary role is be a counseling unit regarding technology R&D issues for Israel government and related technology Ministries. As for MOLMOP’s responsibilities, which include providing advices regarding the government’s yearly and long-term national technology R&D policies, providing the priority development suggestion, and providing the suggestions for the execution of R&D basic infrastructure and research plans. B.The Management and Subsidy of Israel’s Technology plans Regarding the institute for the management and the subsidy of Israel’s technology plans, it will be different because of grantee. Israel Science Foundation (ISF) takes responsibility for the subsidy and the management of fundamental research plans in colleges, and its grantees are mainly focused on Israel’s colleges, high education institutes, medical centers and research institutes or researchers whose areas are in science and technical, life science and medicine, and humanity and social science. As for the budget of ISF, it mainly comes from the Planning and Budgeting Committee (PBC) in Israel Council for Higher Education. In addition, the units, taking charge of the management and the subsidy of technology plans in the government, are the Offices of the Chief Scientist in Ministries. Israel individually forms the Office of the Chief Scientist in the Ministry of Agriculture and Rural Development, the Ministry of Communications, the Ministry of Defense, the Ministry of National Infrastructures, Energy and Water Resources, the Ministry of Health and the Ministry of Economy. The function of the Office of the Chief Scientist not only promotes and inspires R&D innovation in high technology industries that the Office the Chief Scientist takes charge, but also executes Israel’s national plans and takes a responsibility for industrial R&D. Also, the Office of the Chief Scientist has to provide aid supports for those industries or researches, which can assist Israel’s R&D to upgrade; besides, the Office of the Chief Scientists has to provide the guide and training for enterprises to assist them in developing new technology applications or broadening an aspect of innovation for industries. Further, the Office of the Chief Scientists takes charge of cross-country R&D collaboration, and wishes to upgrade Israel’s technical ability and potential in the area of technology R&D and industry innovation by knowledge-sharing and collaboration. III.The Recent Situation of the Management and the Distribution of Israel’s Technology Budget A.The Distribution of Israel’s Technology R&D Budgets By observing Israel’s national expenditures on civilian R&D occupied high share of GDP, Israel’s government wants to promote the ability of innovation in enterprises, research institutes or universities by providing national resources and supports, and directly or indirectly helps the growth of industry development and enhances international competitiveness. However, how to distribute budgets appropriately to different Ministries, and make budgets can match national policies, it is a key point for Israel government to think about. Following the Israeli Central Bureau of Statistics records, Israel’s technology R&D budgets are mainly distributed to some Ministries, including the Ministry of Science and Technology, the Ministry of Economy, the Ministry of Agriculture and Rural Development, the Ministry of National Infrastructures, Energy and Water Resources, the Israel Council for Higher Education and other Ministries. As for the share of R&D budgets, the Ministry of Science and Technology occupies the share of 1.7%, the Ministry of Economy is 35%, the Israel Council for Higher Education is 45.5%, the Ministry of Agriculture and Rural Development is 8.15%, the Ministry of National Infrastructures, Energy and Water Resources is 1.1%, and other Ministries are 7.8% From observing that Israel R&D budgets mainly distributed to several specific Ministries, Israel government not only pours in lot of budgets to encourage civilian technology R&D, to attract more foreign capitals to invest Israel’s industries, and to promote the cooperation between international and domestic technology R&D, but also plans to provide higher education institutes with more R&D budgets to promote their abilities of creativity and innovation in different industries. In addition, by putting R&D budgets into higher education institutes, it also can indirectly inspire students’ potential innovation thinking in technology, develop their abilities to observe the trend of international technology R&D and the need of Israel’s domestic industries, and further appropriately enhance students in higher education institutes to transfer their knowledge into the society. B.The Management of Israel’s Technology R&D Budgets Since Israel is a cabinet government, the cabinet takes responsibility for making all national technology R&D policies. The Ministers Committee for Science and Technology not only has a duty to coordinate Ministries’ technology policies, but also has a responsibility for making a guideline of Israel’s national technology development. The determination of Israel’s national technology development guideline is made by the cabinet conference lead by the Prime Minister, other Ministries does not have any authority to make national technology development guideline. Aforementioned, Israel’s national technology R&D budgets are mainly distributed to several specific Ministries, including the Ministry of Science and Technology, the Ministry of Economy, the Ministry of Agriculture and Rural Development, the Ministry of National Infrastructures, Energy and Water Resources, the Israel Council for Higher Education, and etc. As for the plan management units and plan execution units in Ministries, the Office of the Chief Scientist is the plan management unit in the Ministry of Science and Technology, and Regional Research and Development Centers is the plan execution unit; the Office of the Chief Scientist is the plan management unit in the Ministry of Economy, and its plan execution unit is different industries; the ISF is the plan management units in the Israel Council for Higher Education; also, the Office of the Chief Scientist is the plan management unit in the Ministry of Agriculture, and its plan execution units include the Institute of Field and Garden Corps, the Institute of Horticulture, the Institute of Animal, the Institute of Plan Protection, the Institute of Soil, Water & Environmental Sciences, the Institute for Technology and Storage of Agriculture Products, the Institute of Agricultural Engineering and Research Center; the Office of the Chief Scientist is the plan management unit in the Ministry of National Infrastructures, Energy and Water Resources, and its plan execution units are the Geological Survey of Israel, Israel Oceanographic and Limnological Research and the Institute of Earth and Physical. As for other Ministries, the Offices of the Chief Scientist are the plan management units for Ministries, and the plan execution unit can take Israel National Institute for Health Policy Research or medical centers for example.

TOP