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.
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.
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.
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.
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.
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 Planed Major Promoting Program for Biotechnology and Pharmaceutical IndustryTaiwan Government Lauched the “Biotechnology Action Plan” The Taiwan Government has planned to boost the support and develop local industries across the following six major sectors: biotechnology, tourism, health care, green energy, innovative culture and post-modern agriculture. As the biotechnology industry has reached its maturity by the promulgation of "Biotech and New Pharmaceutical Development Act" in July, 2007, it will be the first to take the lead among the above sectors. Thus, the Executive Yuan has launched the Biotechnology Action Plan as the first project in building the leading industry sectors, to upgrade local industries and stimulate future economic growth. Taiwan Government Planed to Promote the Biotechnology and Other newly Industries by Investing Two Hundred Billion To expand every industrial scale, enhance industrial value, increase the value around the main industrial field, and to encourage the industrial development by government investments for creating the civil working opportunities to reach the goal of continuous economic development, the Executive Yuan Economic Establishment commission has expressed that, the government has selected six newly industrials including "Biotechnology", "Green Energy", "Refined Agriculture", "Tourism", "Medicare", and "Culture Originality" on November 19, 2009 to promote our national economic growth. The government will invest two hundred billion NT dollars to support the industrial development aggressively and to enhance the social investments from year 2009 to 2012. According to a Chung-Hua Institution for Economic Research report, the future growth rate will reach 8.16% after the evaluation, Hence, the future of the industries seems to be quite bright. Currently, the government plans to put money into six newly industries through the existing ways for investment. For instance, firstly, in accordance with the "Act For The Development Of Biotech And New Pharmaceuticals Industry" article 5 provision 1 ",for the purpose of promoting the Biotech and New Pharmaceuticals Industry, a Biotech and New Pharmaceuticals Company may, for a period of five years from the time it is subject to corporate income tax, enjoy a reduction in its corporate income tax payable for up to thirty-five percent (35%) of the total funds invested in research and development ("R&D") and personnel training each year; provided, however, that if the R&D expenditure of a particular year exceeds the average R&D expenditure of the previous two years or if the personnel training expenditure of a particular year exceeds the average personnel training expenditure of the previous two years, fifty percent (50%) of the amount in excess of the average may be used to credit against the amount of corporate income tax payable. Secondly, according to same act of the article 6 provision 1 ", in order to encourage the establishment or expansion of Bio tech and New Pharmaceuticals Companies, a profit-seeking enterprise that (i) subscribes for the stock issued by a Biotech and New Pharmaceuticals Company at the time of the latter's establishment or subsequent expansion; and (ii) has been a registered shareholder of the Biotech and New Pharmaceuticals Company for a period of three (3) years or more, may, for a period of five years from the time it is subject to corporate income tax, enjoy a reduction in its corporate income tax payable for up to twenty percent (20%) of the total amount of price paid for the subscription of shares in such Biotech and New Pharmaceuticals Company; provided that such Biotech and New Pharmaceuticals Company has not applied for exemption from corporate income tax or shareholders investment credit based on the subscription price under other applicable laws and regulations. Thirdly, to promote the entire biotechnological industry development, the government has drafted the "Biotechnology Takeoff Package" for subsidizing the startup´s social investment companies which can satisfy the conditions to invest in "Drug discovery", "Medical Device" or other related biotech industries up to 5 billion with the capital invest in domestic industry over 50%, , with operating experience of multinational biotech investment companies with capital over 150 million in related industrial fields, and with the working experiences of doctor accumulated up to 60 years. Additionally, the refined agriculture industry field has not only discovered the gene selected products, but also combined the tourism with farming business for new business model creation. According to the "Guidelines for Preferential Loans for the Upgrading of Tourism Enterprises" point 4 provision 1, the expenditure for spending on machine, instruments, land or repairing can be granted a preferential loan in accordance with the rule of point 6, and government will provide a subsidy of interest for loaning Tourism Enterprises with timely payments. At last, Council for Economic Planning and Development also points out because most of technology industry has been impacted seriously by fluctuation of international prosperity due to conducting the export trade oriented strategy. Furthermore, the aspects of our export trade of technology industry have been impacted by the U.S. financial crisis and the economic decay in EU and US; and the industrial development seems to face the problem caused by over centralization in Taiwan. Hence, the current framework of domestic industry should be rearranged and to make it better by promoting the developmental project of six newly industries. Taiwan Government Had Modifies Rules to Accelerate NDA Process and Facilitate Development of Clinical Studies in Taiwan In July 2007, the "Biotech and New Pharmaceutical Development Act" modified many regulations related to pharmaceutical administration, taxes, and professionals in Taiwan. In addition, in order to facilitate the development of the biotechnology and pharmaceutical industries, the government has attempted to create a friendly environment for research and development by setting up appropriate regulations and application systems. These measures show that the Taiwanese government is keenly aware that these industries have huge potential value. To operate in coordination with the above Act and to better deal with the increasing productivity of pharmaceutical R&D programs in Taiwan, the Executive Yuan simplified the New Drug Application (NDA) process to facilitate the submission that required Certificate of Pharmaceutical Product (CPP) for drugs with new ingredients. The current NDA process requires sponsors to submit documentation as specified by one of the following four options: (1) three CPPs from three of "ten medically-advanced countries," including Germany, the U.S., England, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden; (2) one CPP from the U.S., Japan, Canada, Australia, or England and one CPP from Germany, France, Switzerland, Sweden, or Belgium; (3) a Free Sale Certificate (FSC) from one of ten medically-advanced countries where the pharmaceuticals are originally produced and one CPP from one of the other nine countries; or (4) a CPP from the European Medicines Agency. Thus, the current NDA process requires sponsors to spend inordinate amounts of time and incur significant costs to acquire two or three FSCs or CPPs from ten medically-advanced countries in order to submit an NDA in Taiwan. According to the new rules, sponsors will not have to submit above CPPs if (1) Phase I clinical studies have been conducted in Taiwan, and Phase III Pivotal Trial clinical studies have been simultaneously conducted both in Taiwan and in another country or (2) Phase II and Phase III Pivotal Trial clinical studies have been simultaneously conducted both in Taiwan and in another country. Besides, the required minimum numbers of patients were evaluated during each above phase. Therefore, sponsors who conduct clinical studies in Taiwan and in another country simultaneously could reduce their costs and shorten the NDA process in Taiwan. The new rules aim to encourage international pharmaceutical companies to conduct clinical studies in Taiwan or to conduct such studies cooperatively with Taiwanese pharmaceutical companies. Such interactions will allow Taiwanese pharmaceutical companies to participate in development and implementation of international clinical studies in addition to benefiting from the shortened NDA process. Therefore, the R&D abilities and the internationalization of the Taiwanese pharmaceutical industry will be improved.
Innovative Practice of Israel's Government ProcurementInnovative Practice of Israel's Government Procurement Government procurement is an important pillar of government services. Because of the huge number of government purchases, government procurement management play an important role in promoting public sector efficiency and building citizenship. Well-designed government procurement systems also help to achieve policy such as environmental protection, innovation, start-ups and the development of small and medium-sized enterprises. Nowadays, countries in the world, especially OECD countries, have been widely practiced with innovative procurement to stimulate innovation and start-ups, and call Innovation procurement can deliver solutions to challenges of public interest and ICTs can play a major role in this. However, in the OECD countries, in addition to the advanced countries that have been developed, many developing countries have also used government procurement to stimulate national R & D and innovation with remarkable results. Israel is one of the world's leading technology innovation centers, one of the most innovative economies in the world, continues to leverage its own strengths, support of technology entrepreneurship and unique environment, an international reputation in the high-tech industry, the spirit of technological innovation and novelty. Government procurement is a core element of the activities of Israeli government, agreement with suppliers and compliance with the Mandatory Tenders Law. The main challenge is how to ensure efficiency and maintain government performance while ensuring an equitable and transparent procurement process. Israel’s Mandatory Tenders Law has shown the central role played by the Israeli Supreme Court in creating and developing this law, even in the absence of any procurement legislation, based instead on general principles of administrative law. Once the project of creating a detailed body of public tendering law had been completed, and the legislator was about to step in, the Supreme Court was prepared to step out and transferring the jurisdiction to lower courts. The Knesset passed the Mandatory Tenders Law, and based on it the Government issued the various tendering regulations. Besides, Israel's various international agreements on government procurement, mainly GPA and other bilateral international agreements such as free trade agreements with Mexico and Colombia and free trade agreements and memoranda of understanding with the United States. The practical significance of these commitments can only be understood on the backdrop of Israel’s domestic preference and offset policies. These policies were therefore discussed and analyzed as they apply when none of the international agreements applies. The Challenge Tenders "How to solve the problem of overcrowding in the emergency department and the internal medicine department?" is the first of a series of "problem solicitations" released by the Israeli Ministry of Health which seeks to find a digital solution to the public health system problem, questions from the government while avoiding preconceived prejudices affect the nature of the solution, allowing multiple innovative ideas from different fields to enter the health system, make fair and transparent judgments about the ideal solution to the problem. In order to ensure transparency and integrity, equality, efficiency and competition in the decision-making process, the tender proposed by the Israeli Ministry of Health defines a two-stage tender process. The Ministry of Health of Israel, in order to improve the quality of medical care, shorten the waiting time for hospitalized patients, protect the dignity of patients and their families with patients as its center, and ensure their rights, while alleviating the burden of hospital staff, so as to pass the targeted treatment areas reduce the gap between various residential areas. The Israeli government deals with these issues through challenging tenders and offers a digital solution combined with innovative ideas. The initiative proposed through the development of public service projects can raise the level of public services in the country and help the government to reduce costs and achieve the purpose of promoting innovation with limited conceptual, technical and financial capabilities. In addition, due to the online operation of the challenging tender process throughout the entire process, fair and transparent procedures can be ensured, while public-private partnerships are encouraged to facilitate the implementation of the implementation plan.
Hard Law or Soft Law? –Global AI Regulation Developments and Regulatory ConsiderationsHard Law or Soft Law? –Global AI Regulation Developments and Regulatory Considerations 2023/08/18 Since the launch of ChatGPT on November 30, 2022, the technology has been disrupting industries, shifting the way things used to work, bringing benefits but also problems. Several law suits were filed by artists, writers and voice actors in the US, claiming that the usage of copyright materials in training generative AI violates their copyright.[1] AI deepfake, hallucination and bias has also become the center of discussion, as the generation of fake news, false information, and biased decisions could deeply affect human rights and the society as a whole.[2] To retain the benefits of AI without causing damage to the society, regulators around the world have been accelerating their pace in establishing AI regulations. However, with the technology evolving at such speed and uncertainty, there is a lack of consensus on which regulation approach can effectively safeguard human rights while promoting innovation. This article will provide an overview of current AI regulation developments around the world, a preliminary analysis of the pros and cons of different regulation approaches, and point out some other elements that regulators should consider. I. An overview of the current AI regulation landscape around the world The EU has its lead in legislation, with its parliament adopting its position on the AI ACT in June 2023, heading into trilogue meetings that aim to reach an agreement by the end of this year.[3] China has also announced its draft National AI ACT, scheduled to enter its National People's Congress before the end of 2023.[4] It already has several administration rules in place, such as the 2021 regulation on recommendation algorithms, the 2022 rules for deep synthesis, and the 2023 draft rules on generative AI.[5] Some other countries have been taking a softer approach, preferring voluntary guidelines and testing schemes. The UK published its AI regulation plans in March, seeking views on its sectoral guideline-based pro-innovation regulation approach.[6] To minimize uncertainty for companies, it proposed a set of regulatory principles to ensure that government bodies develop guidelines in a consistent manner.[7] The US National Institute of Standards and Technology (NIST) released the AI Risk Management Framework in January[8], with a non-binding Blueprint for an AI Bill of Rights published in October 2022, providing guidance on the design and use of AI with a set of principles.[9] It is important to take note that some States have drafted regulations on specific subjects, such as New York City’s Final Regulations on Use of AI in Hiring and Promotion came into force in July 2023.[10] Singapore launched the world’s first AI testing framework and toolkit international pilot in May 2022, with the assistance of AWS, DBS Bank, Google, Meta, Microsoft, Singapore Airlines, etc. After a year of testing, it open-sourced the software toolkit in July 2023, to better develop the system.[11] There are also some countries still undecided on their regulation approach. Australia commenced a public consultation on its AI regulatory framework proposal in June[12], seeking views on its draft AI risk management approach.[13] Taiwan’s government announced in July 2023 to propose a draft AI basic law by September 2023, covering topics such as AI-related definition, privacy protections, data governance, risk management, ethical principles, and industrial promotion.[14] However, the plan was recently postponed, indicating a possible shift towards voluntary or mandatory government principles and guidance, before establishing the law.[15] II. Hard law or soft law? The pros and cons of different regulatory approaches One of the key advantages of hard law in AI regulation is its ability to provide binding legal obligations and legal enforcement mechanisms that ensure accountability and compliance.[16] Hard law also provides greater legal certainty, transparency and remedies for consumers and companies, which is especially important for smaller companies that do not have as many resources to influence and comply with fast-changing soft law.[17] However, the legislative process can be time-consuming, slower to update, and less agile.[18] This poses the risk of stifling innovation, as hard law inevitably cannot keep pace with the rapidly evolving AI technology.[19] In contrast, soft law represents a more flexible and adaptive approach to AI regulation. As the potential of AI still remains largely mysterious, government bodies can formulate principles and guidelines tailored to the regulatory needs of different industry sectors.[20] In addition, if there are adequate incentives in place for actors to comply, the cost of enforcement could be much lower than hard laws. Governments can also experiment with several different soft law approaches to test their effectiveness.[21] However, the voluntary nature of soft law and the lack of legal enforcement mechanisms could lead to inconsistent adoption and undermine the effectiveness of these guidelines, potentially leaving critical gaps in addressing AI's risks.[22] Additionally, in cases of AI-related harms, soft law could not offer effective protection on consumer rights and human rights, as there is no clear legal obligation to facilitate accountability and remedies.[23] Carlos Ignacio Gutierrez and Gary Marchant, faculty members at Arizona State University (ASU), analyzed 634 AI soft law programs against 100 criteria and found that two-thirds of the program lack enforcement mechanisms to deliver its anticipated AI governance goals. He pointed out that credible indirect enforcement mechanisms and a perception of legitimacy are two critical elements that could strengthen soft law’s effectiveness.[24] For example, to publish stem cell research in top academic journals, the author needs to demonstrate that the research complies with related research standards.[25] In addition, companies usually have a greater incentive to comply with private standards to avoid regulatory shifts towards hard laws with higher costs and constraints.[26] III. Other considerations Apart from understanding the strengths and limitations of soft law and hard law, it is important for governments to consider each country’s unique differences. For example, Singapore has always focused on voluntary approaches as it acknowledges that being a small country, close cooperation with the industry, research organizations, and other governments to formulate a strong AI governance practice is much more important than rushing into legislation.[27] For them, the flexibility and lower cost of soft regulation provide time to learn from industries to prevent forming rules that aren’t addressing real-world issues.[28] This process allows preparation for better legislation at a later stage. Japan has also shifted towards a softer approach to minimize legal compliance costs, as it recognizes its slower position in the AI race.[29] For them, the EU AI Act is aiming at regulating Giant Tech companies, rather than promoting innovation.[30] That is why Japan considers that hard law does not suit the industry development stage they’re currently in.[31] Therefore, they seek to address legal issues with current laws and draft relevant guidance.[32] IV. Conclusion As the global AI regulatory landscape continues to evolve, it is important for governments to consider the pros and cons of hard law and soft law, and also country-specific conditions in deciding what’s suitable for the country. Additionally, a regular review on the effectiveness and impact of their chosen regulatory approach on AI’s development and the society is recommended. 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[13] Australian Government Department of Industry, Science and Resources, Safe and responsible AI in Australia (2023), https://storage.googleapis.com/converlens-au-industry/industry/p/prj2452c8e24d7a400c72429/public_assets/Safe-and-responsible-AI-in-Australia-discussion-paper.pdf (last visited Aug 10, 2023). [14] 張璦,中央通訊社,AI基本法草案聚焦隱私保護、應用合法性等7面向 擬設打假中心,https://www.cna.com.tw/news/ait/202307040329.aspx (最後瀏覽日:2023/08/10)。 [15] 蘇思云,中央通訊社,2023/08/01,鄭文燦:考量技術發展快應用廣 AI基本法延後提出,https://www.cna.com.tw/news/afe/202308010228.aspx (最後瀏覽日:2023/08/10)。 [16] supra, note 13, at 27. [17] id. [18] id., at 28. [19] Soft law as a complement to AI regulation, Brookings, https://www.brookings.edu/articles/soft-law-as-a-complement-to-ai-regulation/ (last visited Aug 10, 2023). [20] supra, note 5. [21] Gary Marchant, “Soft Law” Governance of Artificial Intelligence (2019), https://escholarship.org/uc/item/0jq252ks (last visited Aug 10, 2023). [22] How soft law is used in AI governance, Brookings,https://www.brookings.edu/articles/how-soft-law-is-used-in-ai-governance/ (last visited Aug 10, 2023). [23] supra, note 13, at 27. [24] Why Soft Law is the Best Way to Approach the Pacing Problem in AI, Carnegie Council for Ethics in International Affairs,https://www.carnegiecouncil.org/media/article/why-soft-law-is-the-best-way-to-approach-the-pacing-problem-in-ai (last visited Aug 10, 2023). [25] id. [26] id. [27] Singapore is not looking to regulate A.I. just yet, says the city-state’s authority, CNBC,https://www.cnbc.com/2023/06/19/singapore-is-not-looking-to-regulate-ai-just-yet-says-the-city-state.html#:~:text=Singapore%20is%20not%20rushing%20to,Media%20Development%20Authority%2C%20told%20CNBC (last visited Aug 10, 2023). [28] id. [29] Japan leaning toward softer AI rules than EU, official close to deliberations says, Reuters, https://www.reuters.com/technology/japan-leaning-toward-softer-ai-rules-than-eu-source-2023-07-03/ (last visited Aug 10, 2023). [30] id. [31] id. [32] id.