Research on Taiwan’s Policies of Innovative Industry Development in Recent Years (2015-2016)
1. “Five plus Two” Innovative Industries Policy
On June 15, 2016, Premier Lin Chuan met with a group of prominent business leaders to talk about a government project on five innovative industries, which aim to drive the next generation of businesses in R.O.C.. Subsequently the program was expanded to include “new agriculture” and the “circular economy” as the “+2.” The program was then broadened even further to include the Digital Economy and Cultural Innovation, with even Semiconductors and IC Design included, although the name of the policy remains 5+2. Speaking at the Third Wednesday Club in Taipei, Premier Lin said the industries require more investment to drive the next generation of industry growth momentum in R.O.C., create high-quality jobs, and upgrade the industrial competitiveness. Executive Yuan has selected the five innovative industries of Asia Silicon Valley, smart machinery, green energy, biotech & pharmaceutical industry, and national defense, which will be the core for pushing forward the next-generation industrial growth and improve overall environment by creating a cluster effect that links local and global industries, while simultaneously raising wages and stimulating employment.
Premier Lin said, regarding industrial competitiveness and investment issues the lackluster economy has stifled investment opportunities, and with limited government budgets, the private sector must play the larger role in investments. Regarding the “Five major Innovative Industries” project, Premier Lin said the National Development Council is currently drafting long-term plan to attract talent, create a thriving working environment, and infuse companies with more innovation, entrepreneurship and young workers. In addition, R.O.C. must also cultivate a strong software industry, without which it would be difficult to build a highly intelligent infrastructure.
The National Development Council said the program possess both the capacity of domestic demand and local characteristics, as the core for pushing forward the next-generation industrial growth. The government aims to promote a seamless synergy of investment, technology, and the talent, in order to develop innovative industrial clusters for furthering global linkage and nurturing international enterprises. In the meantime, the government also aims at achieving the enhancement of technology levels, balanced regional development, as well as realizing the benefits of job creation.
2. The Asia Silicon Valley Development Plan
In September 2016 the government approved the Asia Silicon Valley Development Plan, which connect Taiwan to global tech clusters and create new industries for the next generation. By harnessing advanced technological research and development results from around the world, the plan hopes to promote innovation and R&D for devices and applications of the internet of things (IoT), and upgrade Taiwan’s startup and entrepreneurship ecosystem.
The four implementation strategies are as follows:
(1) Building a comprehensive ecosystem to support innovation and entrepreneurship
(2) Connect with international research and development capabilities
(3) Create an IoT value chain
(4) Construct diversified test beds for smart products and services by establishing a quality internet environment
Taiwan’s first wave of industrial development was driven by continuous technological innovation, and the wave that followed saw the information industry become a major source of economic growth.
3. Global Hub for Smart Machinery
On July 21, 2016, Premier Lin Chuan said at a Cabinet meeting, the government aims to forge Taiwan into a global manufacturing hub for intelligent machinery and high-end equipment parts. Upgrading from precision machinery to intelligent machinery is the main goal of putting intelligent machinery industry into focal execution area expecting to create jobs and to maximize the production of production line as well as to forge central Taiwan into a global manufacturing hub for smart machinery. The Ministry of Economic draws up the Intelligent Machinery Promotion Program to establish the applications of the technology and capacity of services that fit the demand of the market. The program embodies two parts. The first is to accelerate the industrialization of intelligent machinery for building an ecosystem. The second is to improve intelligentization by means of introducing the intelligent machinery into the industries.
The execution policy of the Intelligent Machinery Promotion Program is to integrate the intelligent functions such as malfunctions predictions, accuracy compensation, and automatic parameter setting into the machinery industry so as to have the ability to render the whole solutions to the problem. Simultaneously, the program employs three strategies, which are connecting with the local industries, connecting with the future, and connecting with the world, to develop the mentioned vision and objectives. Especially, the way to execute the strategy of connecting with the local industries consists of integrating the capabilities of industry, research organization and the government. At the meantime, the government will encourage the applications of smart vehicles and unmanned aerial vehicles and train the talents as well. The thinking of connecting with the future lies in the goal of deepening the technologies, establishing systematic solutions, and providing a testing areas, which focus on the related applications such as aerospace, advanced semiconductor, smart transportation, green vehicles, energy industry, whole solutions between factories, intelligent man-machine coordination, and robots of machine vision combined with intelligent machinery applications. The government would strengthen the cross-cutting cooperation to develop machines for aerospace and integrate the system of industrial division to form a cluster in order to create Taiwanese IoT technology. Eventually, Taiwan will be able to connect with the world, enhance international cooperation, expand export trade and push industry moving toward the age of information and digital economy and break the edge of industry technology to make the industry feel the goodwill of the government.
4. Green energy innovations
The government’s “five plus two” innovative industries program includes a green energy industrial innovation plan passed October 27, 2016 that will focus on Taiwan’s green needs, spur extensive investments from within and outside the country, and increase quality employment opportunities while supporting the growth of green energy technologies and businesses.
The government is developing the Shalun Green Energy Science City. The hub’s core in Shalun will house a green energy technology research center as well as a demo site, providing facilities to develop research and development (R&D) capabilities and conduct the requisite certification and demonstration procedures. The joint research center for green energy technologies will integrate the efforts of domestic academic institutions, research institutes, state-run enterprises and industry to develop green energy technologies, focusing on four major functions: creating, conserving and storing energy, as well as system integration. Development strategies include systems integration and finding better ways to conserve, generate and store energy by promoting green energy infrastructure, expanding renewable energy capabilities and cooperating with large international firms.
The emergence of the green economy has prompted the government to build infrastructure that will lay the foundation for Taiwan’s green energy sector, transform the nation into a nuclear-free society, and spur industrial innovation. For innovative technology industries, green energy industries can drive domestic economic development by attracting more venture capital and creating more employment opportunities.
5. Biomedical Industry Innovation Program
To facilitate development of Taiwan’s biomedical industry, the government proposed a “biomedical industrial innovation promotion program” on November 10, 2016 to serve as the nation’s new blueprint for innovative biomedical research and development (R&D). To facilitate development of the biomedical industry, the government proposed a “biomedical industrial innovation promotion program”. The program centered on the theme of “local, global and future links,” “the biomedical industrial innovation promotion program” includes four action plans:
(1) Build a comprehensive ecosystem
To address a rapidly ageing global population, Taiwan will enhance the biomedical industry’s capacity for innovation by focusing on talent, capital, topic selection, intellectual property, laws and regulations, and resources.
(2) Integrate innovative business clusters
Established by the Ministry of Science and Technology and based in Hsinchu Biomedical Science Park, the center will serve as a government think tank on related issues. It is also tasked with initiating and advancing exchanges among local and foreign experts, overseeing project implementation, promoting investment and recruiting talents. Equally important, it will play a central role in integrating resources from other biomedical industry clusters around the country, including Nangang Software Park in Taipei City, Central Taiwan Science Park in Taichung City and Southern Science Park in Tainan City.
(3) Connect global market resources
Building on Taiwan’s advantages, promote M&A and strategic alliances, and employ buyout funds and syndicated loans to purchase high-potential small and medium-sized international pharmaceutical companies, medical supply companies, distributors and service providers. Use modern mosquito-borne disease control strategies as the foundation of diplomatic cooperation, and promote the development of Taiwan’s public health care and medical services in Southeast Asian countries.
(4) Promote specialized key industries
Promote niche precision medical services, foster clusters of world-class specialty clinics, and develop industries in the health and wellness sectors.
6. DIGITAL NATION AND INNOVATIVE ECONOMIC DEVELOPMENT PLAN
On November 24, 2016, the Executive Yuan promote the Digital Nation and Innovative Economic Development Plan (2017-2025) (DIGI+ program), the plan’s main goals for 2025 are to grow R.O.C.’s digital economy to NT $ 6.5 trillion (US$205.9 billion), increase the digital lifestyle services penetration rate to 80 percent, speed up broadband connections to 2 Gbps, ensure citizens’ basic rights to have 25 Mbps broadband access, and put R.O.C. among the top 10 information technology nations worldwide.
In addition to the industrial economy, the program can jump off bottlenecks in the past industrial development, and promote the current Internet of things, intelligent machinery, green energy, medical care and other key national industries, but also attaches great importance to strengthening the digital infrastructure construction, the development of equal active, as well as the creation of a service-oriented digital government. It is also hoped that through the construction of a sustainable and intelligent urban and rural area, the quality of life will be improved and the people will enjoy a wealthy and healthy life. Over the next 8 years, the government will spend more than NT $ 150 billion.
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 R.O.C.’s standing in the global digital service economy.
The program aims to build a favorable environment for digital innovation and to create a friendly legal environment to complete the draft amendments to the Digital Communications Law and the Telecommunications Act as soon as possible, foster cross-domain digital talents and develop advanced digital technologies, To create a digital economy, digital government, network society, smart urban and rural and other national innovation ecological environment in order to achieve "the development of active network society, promote high value innovation economy, open up rich countries of the policy vision.
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.
7. “NEW AGRICULTURE” PROMOTION PROJECT
At a Cabinet meeting On December 08, 2016, Premier Lin Chuan underscored the importance of a new agricultural paradigm for Taiwan’s economic development, adding that new agriculture is an integral part of the “five plus two” industrial innovation projects proposed by President Tsai Ing-wen. The “new agriculture” promotion project uses innovation technology to bring value to agricultural, and build new agricultural paradigm, agricultural safety systems and promote agricultural marketing. This project also takes resources recycling and environmental sustainability into consideration to promote agricultural transformation, and build a robust new agricultural system.
This agricultural project is expected to increase food self-sufficiency rate to 40%, level up agricultural industry value by NT$43.4 billion, create 370,000 jobs and increase portion of total agricultural exports to new overseas markets to 57% by 2020.
This project contains three aspects:
First is “building new agricultural paradigm”: to protect farmers, agricultural development and ensure sustainability of the environment.
Second is “building agricultural safety systems”: Ensuring product safety and quality, and building a certification system which can be trust by the consumers and is consistent with international standards.
Last but not least is “leveling up agricultural marketing and promotions”: enhancing promotion, making the agricultural industry become profitable and sustainable.
Council of Agriculture’s initiatives also proposed 10 policies to leverage agricultural industry, not only just use the passive subsidies measure of the past. These policies including promoting environmentally friendly farming practices; giving farmers that are beneficial(green) to the land payments; stabilizing farmers’ incomes; increasing the competitiveness of the livestock and poultry industries; using agricultural resources sustainably; ensuring the safety of agricultural products; developing technological innovation; leveling up food security; increasing diversification of domestic and external marketing channels; and increasing agriculture industry added value.
In this statutes report, Council of Agriculture said this project will accelerate reforms, create new agricultural models and safety systems, but also build a new sustainable paradigm of agricultural. Premier Lin Chuan also backed this “five plus two innovative industries” program and “new agriculture” project, and asked Council of Agriculture to reviewing the possible legal changes or amendment that may help to enhance the transformation of agricultural sector.
Blockchain and General Data Protection Regulation (GDPR) compliance issues (2019) I. Brief Blockchain technology can solve the problem of trust between data demanders and data providers. In other words, in a centralized mode, data demanders can only choose to believe that the centralized platform will not contain the false information. However, in the decentralized mode, data isn’t controlled by one individual group or organization[1], data demanders can directly verify information such as data source, time, and authorization on the blockchain without worrying about the correctness and authenticity of the data. Take the “immutable” for example, it is conflict with the right to erase (also known as the right to be forgotten) in the GDPR.With encryption and one-time pad (OTP) technology, data subjects can make data off-chain storaged or modified at any time in a decentralized platform, so the problem that data on blockchain not meet the GDPR regulation has gradually faded away. II. What is GDPR? The purpose of the EU GDPR is to protect user’s data and to prevent large-scale online platforms or large enterprises from collecting or using user’s data without their permission. Violators will be punished by the EU with up to 20 million Euros (equal to 700 million NT dollars) or 4% of the worldwide annual revenue of the prior financial year. The aim is to promote free movement of personal data within the European Union, while maintaining adequate level of data protection. It is a technology-neutral law, any type of technology which is for processing personal data is applicable. So problem about whether the data on blockchain fits GDPR regulation has raise. Since the blockchain is decentralized, one of the original design goals is to avoid a large amount of centralized data being abused. Blockchain can be divided into permissioned blockchains and permissionless blockchains. The former can also be called “private chains” or “alliance chains” or “enterprise chains”, that means no one can join the blockchain without consent. The latter can also be called “public chains”, which means that anyone can participate on chain without obtaining consent. Sometimes, private chain is not completely decentralized. The demand for the use of blockchain has developed a hybrid of two types of blockchain, called “alliance chain”, which not only maintains the privacy of the private chain, but also maintains the characteristics of public chains. The information on the alliance chain will be open and transparent, and it is in conflict with the application of GDPR. III. How to GDPR apply to blockchain ? First, it should be determined whether the data on the blockchain is personal data protected by GDPR. Second, what is the relationship and respective responsibilities of the data subject, data controller, and data processor? Finally, we discuss the common technical characteristics of blockchain and how it is applicable to GDPR. 1. Data on the blockchain is personal data protected by GDPR? First of all, starting from the technical characteristics of the blockchain, blockchain technology is commonly decentralized, anonymous, immutable, trackable and encrypted. The other five major characteristics are immutability, authenticity, transparency, uniqueness, and collective consensus. Further, the blockchain is an open, decentralized ledger technology that can effectively verify and permanently store transactions between two parties, and can be proved. It is a distributed database, all users on the chain can access to the database and the history record, also can directly verify transaction records. Each nodes use peer-to-peer transmission for upload or transfer information without third-party intermediation, which is the unique “decentralization” feature of the blockchain. In addition, the node or any user on the chain has a unique and identifiable set of more than 30 alphanumeric addresses, but the user may choose to be anonymous or provide identification, which is also a feature of transparency with pseudonymity[2]; Data on blockchain is irreversibility of records. Once the transaction is recorded and updated on the chain, it is difficult to change and is permanently stored in the database, that is to say, it has the characteristics of “tamper-resistance”[3]. According to Article 4 (1) of the GDPR, “personal data” means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person. Therefore, if data subject cannot be identified by the personal data on the blockchain, that is an anonymous data, excluding the application of GDPR. (1) What is Anonymization? According to Opinion 05/2014 on Anonymization Techniques by Article 29 Data Protection Working Party of the European Union, “anonymization” is a technique applied to personal data in order to achieve irreversible de-identification[4]. And it also said the “Hash function” of blockchain is a pseudonymization technology, the personal data is possible to be re-identified. Therefore it’s not an “anonymization”, the data on the blockchain may still be the personal data stipulated by the GDPR. As the blockchain evolves, it will be possible to develop technologies that are not regulated by GDPR, such as part of the encryption process, which will be able to pass the court or European data protection authorities requirement of anonymization. There are also many compliance solutions which use technical in the industry, such as avoiding transaction data stored directly on the chain. 2. International data transmission Furthermore, in accordance with Article 3 of the GDPR, “This Regulation applies to the processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union, regardless of whether the processing takes place in the Union or not. This Regulation applies to the processing of personal data of data subjects who are in the Union by a controller or processor not established in the Union, where the processing activities are related to: (a) the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union; or (b) the monitoring of their behaviour as far as their behaviour takes place within the Union”.[5] In other words, GDPR applies only when the data on the blockchain is not anonymized, and involves the processing of personal data of EU citizens. 3. Identification of data controllers and data processors Therefore, if the encryption technology involves the public storage of EU citizens' personal data and passes it to a third-party controller, it may be identified as the “data controller” under Article 4 of GDPR, and all nodes and miners of the platform may be deemed as the “co-controller” of the data, and be assumed joint responsibility with the data controller by GDPR. For example, the parties can claim the right to delete data from the data controller. In addition, a blockchain operator may be identified as a “processor”, for example, Backend as a Service (BaaS) products, the third parties provide network infrastructure for users, and let users manage and store personal data. Such Cloud Services Companies provide online services on behalf of customers, do not act as “data controllers”. Some commentators believe that in the case of private chains or alliance chains, such as land records transmission, inter-bank customer information sharing, etc., compared to public chain applications: such as cryptocurrencies (Bitcoin for example), is not completely decentralized, and more likely to meet GDPR requirements[6]. For example, in the case of a private chain or alliance chain, it is a closed platform, which contains only a small number of trusted nodes, is more effective in complying with the GDPR rules. 4. Data subject claims In accordance with Article 17 of the GDPR, The data subject shall have the right to obtain from the controller the erasure of personal data concerning him or her without undue delay and the controller shall have the obligation to erase personal data without undue delay under some grounds. Off-chain storage technology can help the blockchain industry comply with GDPR rules, allowing offline storage of personal data, or allow trusted nodes to delete the private key of encrypted information, which leaving data that cannot be read and identified on the chain. If the data is in accordance with the definition of anonymization by GDPR, there is no room for GDPR to be applied. IV. Conclusion In summary, it’s seem that the application of blockchain to GDPR may include: (a) being difficulty to identified the data controllers and data processors after the data subject upload their data. (b) the nature of decentralized storage is transnational storage, and Whether the country where the node is located, is meets the “adequacy decision” of Article 45 of the GDPR. If it cannot be met, then it needs to consider whether it conforms to the transfers subject to appropriate safeguards of Article 46, or the derogations for specific situations of Article 49 of the GDPR. Reference: [1] How to Trade Cryptocurrency: A Guide for (Future) Millionaires, https://wikijob.com/trading/cryptocurrency/how-to-trade-cryptocurrency [2] DONNA K. HAMMAKER, HEALTH RECORDS AND THE LAW 392 (5TH ED. 2018). [3] Iansiti, Marco, and Karim R. Lakhani, The Truth about Blockchain, Harvard Business Review 95, no. 1 (January-February 2017): 118-125, available at https://hbr.org/2017/01/the-truth-about-blockchain [4] Article 29 Data Protection Working Party, Opinion 05/2014 on Anonymisation Techniques (2014), https://www.pdpjournals.com/docs/88197.pdf [5] Directive 95/46/EC (General Data Protection Regulation), https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016R0679&from=EN [6] Queen Mary University of London, Are blockchains compatible with data privacy law? https://www.qmul.ac.uk/media/news/2018/hss/are-blockchains-compatible-with-data-privacy-law.html
Introduction to the “Public Procurement for Startups” mechanismIntroduction to the “Public Procurement for Startups” mechanism I.Backgrounds According to the EU’s statistics, government procurement budget accounted for over 14% of GDP. And, according to the media report, the total amount of government procurement in Taiwan in 2017 accounted for nearly 8%. Therefore, the government’s procurement power has gradually become a policy tool for the government to promote the development of innovative products and services. In 2017, the Executive Yuan of the R.O.C.(Taiwan)announced a government procurement policy named “Government as Good Partners with Startups (政府成為新創好夥伴)”[1] to encourage government agencies and State-owned Enterprises to procure and adopt innovative goods or services provided by startups. This policy was subsequently implemented through an action plan named “Public Procurement for Startups”(新創採購)[2] by the Small and Medium Enterprise Administration(SMEA).The action plan mainly includes two important parts:One created the procurement process for startups to enter the government contracts market through inter-entities contracts. The other accelerated the collaboration of the government agencies and startups through empirical demonstration. II.Facilitating the procurement process for startups to enter the government market In order to help startups enter the government contracts market in a more efficient way, the SMEA conducts the procurement of inter-entity supply contracts with suppliers, especially startups, for the supply of innovative goods or services. An inter-entity supply contract[3] is a special contractual framework, under which the contracting entity on behalf of two or more other contracting parties signs a contract with suppliers and formulates the specifics and price of products or services provided through the public procurement process. Through the process of calling for tenders, price competition and so on, winning tenderers will be selected and listed on the Government E-Procurement System. This framework allows those contracting entities obtain orders and acquire products or services which they need in a more efficient way so it increases government agencies’ willingness to procure and use innovative products and services. From 2018, the SMEA started to undertake the survey of innovative products and services that government agencies usually needed and conducted the procurement of inter-entity supply contracts for two rounds every year. As a result, the SMEA plays an important role to bridge the demand and supply sides for innovative products or services by means of implementing the forth-mentioned survey and procurement process. Moreover, in order to explore more innovative products and services with high quality and suitable for government agencies and public institutions, the SMEA actively networked with various stakeholders, including incubators, accelerators, startups mentoring programs sponsored by private and public sectors and so on. Initially the items to be procured were categorized into four themes which were named the Smart Innovations, the Smart Eco, the Smart Healthcare, and the Smart Security. Later, in order to show the diversity of the innovation of startups which response well to various social issues, from 2019, the SMEA introduced two new theme solicitations titled the Smart Education and the Smart Agriculture to the inter-entities contracts. Those items included the power management systems, the AI automated recognition and image warning system, the chatbot for public service, unmanned flying vehicles, aerial photography services and so on. Take the popular AI image warning system as an example, the system is used by police officers to make instant evidence searching and image recording. Other government agencies apply the innovative system to the investigation of illegal logging and school safety surveillance. Moreover, the SMEA has also offered subsidy for local governments tobuy those items provided by startups. That is the coordinated supporting measure which allows startups the equal playing field to compete with large companies. The Subsidy scheme is based on the Guideline for Subsidies on Procurement of Innovative Products and Services[3] (approved by the Executive Yuan on March 29, 2018 and revised on Feb. 20, 2021). In the Guideline, “innovative products and services” refer to the products, technologies, labor, service flows or items and services rendered with creative activities through deploying scientific or technical means and a certain degree of innovations by startups with less than five years in operation. Such innovative products and services are displayed for the inter-entity supply contractual framework administered by the SMEA for government procurement. III.Accelerating the collaboration of the government agencies and startups through empirical demonstration To assist startups to prove their concepts or services, and become more familiar with the governemnrt’s needs, the SMEA also created a mechanism called the “Solving Governmental Problems by Star-up Innovation”(政府出題˙新創解題). It plans to collect government agencies’ needs, and then solicit innovative proposals from startups. After their proposals are accepted, startups will be given a grant up to one million NT dollars to conduct empirical studies on solution with government agencies for about half a year. Take the cooperation between the “Taoyuan Long Term Care Institute for Older People and the Biotech Startup” for example, a care system with sanitary aids was introduced to provide automatic detection, cleanup and dry services for the patients’discharges, thus saving 95% of cleaning time for caregivers. In the past, caregivers usually spent 4 hours on the average in inspecting old patients, cleaning and replacing their bedsheets as their busy daily routines. Inadequate caregivers makes it difficult to maintain the care quality. If the problem was not addressed immediately, it would make the life of old patients more difficult. IV.Achievements to date Since the promotion of the products and services of the startups and the launch of the “Public Procurement for Startups” program in 2018, 68 startups, with the SMEA’s assistance, have entered the government procurement contracts market, and more than 100 government agencies have adopted the innovative resolutions. With the encouragement for them in adopting and utilizing the fruits of the startups, it has generated more than NT$150 million in cooperative business opportunities. V.Conclusions While more and more startups are obtaining business opportunities from the favorable procurement process, constant innovation remains the key to success. As such, the SMEA has regularly visited the government agencies-buyers to obtain feedbacks from startups so as to adjust and optimize the innovative products or services. The SMEA has also regularly renewed the specifics and items of the procurement list every year to keep introducing and supplying high-quality products or services to the government agencies. Reference: [1] Policy for investment environment optimization for Startups(2017),available athttps://www.ndc.gov.tw/nc_27_28382.(last visited on July 30, 2021 ) [2] https://www.spp.org.tw/spp/(last visited on July 30, 2021 ) [3] Article 93 of Government Procurement Act:I An entity may execute an inter-entity supply contract with a supplier for the supply of property or services that are commonly needed by entities. II The regulations for a procurement of an inter-entity supply contract, the matters specified in the tender documentation and contract, applicable entities, and the related matters shall be prescribed by the responsible entity. [4] https://law.moea.gov.tw/LawContent.aspx?id=GL000555(last visited on July 30, 2021)
Impact of Government Organizational Reform to Research Legal System and Response Thereto (2) – Observation of the Swiss Research Innovation System3.Commission of Technology and Innovation (CTI) The CTI is also an institution dedicated to boosting innovation in Switzerland. Established in 1943, it was known as the Commission for the Promotion of Scientific Research[1]. It was initially established for the purpose of boosting economy and raising the employment rate, and renamed after 1996. The CTI and SNSF are two major entities dedicated to funding scientific research in Switzerland, and the difference between both resides in that the CTI is dedicated to funding R&D of the application technology and industrial technology helpful to Switzerland’s economic development. Upon enforcement of the amended RIPA 2011, the CTI was officially independent from the Federal Office for Professional Education and Technology (OEPT) and became an independent entity entitled to making decisions and subordinated to the Federal Department of Economic Affairs (FDEA) directly[2]. The CTI is subject to the council system, consisting of 65 professional members delegated from industrial, academic and research sectors. The members assume the office as a part time job. CTI members are entitled to making decisions on funding, utilization of resources and granting of CTI Start-up Label independently[3]. The CTI primarily carries out the mission including promotion of R&D of industrial technology, enhancement of the market-orientation innovation process and delivery of R&D energy into the market to boost industrial innovation. For innovation, the CTI's core mission is categorized into[4]: (1)Funding technology R&D activities with market potential The CTI invests considerable funds and resources in boosting the R&D of application technology and industrial technology. The CTI R&D Project is intended to fund private enterprises (particularly small-sized and medium-sized enterprises) to engage in R&D of innovation technology or product. The enterprises may propose their innovative ideas freely, and the CTI will decide whether the funds should be granted after assessing whether the ideas are innovative and potentially marketable[5]. CTI’s funding is conditioned on the industrial and academic cooperation. Therefore, the enterprises must work with at least one research institution (including a university, university of science and technology, or ETH) in the R&D. Considering that small-sized and medium-sized enterprises usually do not own enough working funds, technology and human resources to commercialize creative ideas, the CTI R&D Project is intended to resolve the problem about insufficient R&D energy and funds of small- and medium-sized enterprises by delivering the research institutions’ plentiful research energy and granting the private enterprises which work with research institutions (including university, university of science and technology, or ETH) the fund. Notably, CTI’s funding is applicable to R&D expenses only, e.g., research personnel’s salary and expenditure in equipment & materials, and allocated to the research institutions directly. Meanwhile, in order to enhance private enterprises' launch into R&D projects and make them liable for the R&D success or failure, CTI’s funding will be no more than 50% of the total R&D budget and, therefore, the enterprises are entitled to a high degree of control right in the process of R&D. The industrial types which the CTI R&D Project may apply to are not limited. Any innovative ideas with commercial potential may be proposed. For the time being, the key areas funded by CTI include the life science, engineering science, Nano technology and enabling sciences, etc.[6] It intends to keep Switzerland in the lead in these areas. As of 2011, in order to mitigate the impact of drastic CHF revaluation to the industries, the CTI launched its new R&D project, the CTI Voucher[7]. Given this, the CTI is not only an entity dedicated to funding but also plays an intermediary role in the industrial and academic sectors. Enterprises may submit proposals before finding any academic research institution partner. Upon preliminary examination of the proposals, the CTI will introduce competent academic research institutions to work with the enterprises in R&D, subject to the enterprises' R&D needs. After the cooperative partner is confirmed, CTI will grant the fund amounting to no more than CHF3,500,000 per application[8], provided that the funding shall be no more than 50% of the R&D project expenditure. The CTI R&D Project not only boosts innovation but also raises private enterprises’ willingness to participate in the academic and industrial cooperation, thereby narrowing the gap between the supply & demand of innovation R&D in the industrial and academic sectors. Notably, the Project has achieved remarkable effect in driving private enterprises’ investment in technology R&D. According to statistical data, in 2011, the CTI solicited additional investment of CHF1.3 from a private enterprise by investing each CHF1[9]. This is also one of the important reasons why the Swiss innovation system always acts vigorously. Table 1 2005-2011 Passing rate of application for R&D funding Year 2011 2010 2009 2008 2007 2006 2005 Quantity of applications 590 780 637 444 493 407 522 Quantity of funded applications 293 343 319 250 277 227 251 Pass rate 56% 44% 50% 56% 56% 56% 48% Data source: Prepared by the Study (2)Guiding high-tech start-up Switzerland has learnt that high-tech start-ups are critical to the creation of high-quality employment and boosting of economic growth, and start-ups were able to commercialize the R&D results. Therefore, as of 2001, Switzerland successively launched the CTI Entrepreneurship and CTI Startup to promote entrepreneurship and cultivate high-tech start-ups. 1.CTI Entrepreneurship The CTI Entrepreneurship was primarily implemented by the Venture Lab founded by CTI investment. The Venture Lab launched a series of entrepreneurship promotion and training courses, covering day workshops, five-day entrepreneurship intensive courses, and entrepreneurship courses available in universities. Each training course was reviewed by experts, and the experts would provide positive advice to attendants about innovative ideas and business models. Data source: Venture Lab Site Fig. 3 Venture Lab Startup Program 2.CTI Startup The CTI is dedicated to driving the economy by virtue of innovation as its priority mission. In order to cultivate the domestic start-ups with high growth potential in Switzerland, the CTI Startup project was launched in 1996[10] in order to provide entrepreneurs with the relevant guidance services. The project selected young entrepreneurs who provided innovative ideas, and guided them in the process of business start to work their innovative ideas and incorporate competitive start-ups. In order to enable the funding and resources to be utilized effectively, the CTI Startup project enrolled entrepreneurs under very strict procedure, which may be categorized into four stages[11]: Data source: CTI Startup Site Fig. 4 Startup Plan Flow Chart In the first stage, the CTI would preliminarily examine whether the applicant’s idea was innovative and whether it was technologically feasible, and help the applicant register with the CTI Startup project. Upon registration, a more concrete professional examination would be conducted at the second stage. The scope of examination included the technology, market, feasibility and management team’s competence. After that, at the stage of professional guidance, each team would be assigned a professional “entrepreneurship mentor”, who would help the team develop further and optimize the enterprise’s strategy, flow and business model in the process of business start, and provide guidance and advice on the concrete business issues encountered by the start-up. The stage of professional guidance was intended to guide start-ups to acquire the CTI Startup Label, as the CTI Startup Label was granted subject to very strict examination procedure. For example, in 2012, the CTI Startup project accepted 78 applications for entrepreneurship guidance, but finally the CTI Startup Label was granted to 27 applications only[12]. Since 1996, a total of 296 start-ups have acquired the CTI Startup Label, and more than 86% thereof are still operating now[13]. Apparently, the CTI Startup Label represents the certification for innovation and on-going development competence; therefore, it is more favored by investors at the stage of fund raising. Table 2 Execution of start-up plans for the latest three years Quantity of application Quantity of accepted application Quantity of CTI Label granted 2012 177 78 27 2011 160 80 26 2010 141 61 24 Data source: CTI Annual Report, prepared by the Study Meanwhile, the “CTI Invest” platform was established to help start-up raise funds at the very beginning to help commercialize R&D results and cross the valley in the process of R&D innovation. The platform is a private non-business-making organization, a high-tech start-up fund raising platform co-established by CTI and Swiss investors[14]. It is engaged in increasing exposure of the start-ups and contact with investors by organizing activities, in order to help the start-ups acquire investment funds. (3)Facilitating transfer of knowledge and technology between the academic sector and industrial sector KTT Support (Knowledge & Technology Transfer (KTT Support) is identified as another policy instrument dedicated to boosting innovation by the CTI. It is intended to facilitate the exchange of knowledge and technology between academic research institutions and private enterprises, in order to transfer and expand the innovation energy. As of 2013, the CTI has launched a brand new KTT Support project targeting at small-sized and medium-sized enterprises. The new KTT Support project consisted of three factors, including National Thematic Networks (NTNs), Innovation Mentors, and Physical and web-based platforms. Upon the CTI’s strict evaluation and consideration, a total of 8 cooperative innovation subjects were identified in 2012, namely, carbon fiber composite materials, design idea innovation, surface innovation, food study, Swiss biotechnology, wood innovation, photonics and logistics network, etc.[15] One NTN would be established per subject. The CTI would fund these NTNs to support the establishment of liaison channels and cooperative relations between academic research institutions and industries and provide small- and medium-sized enterprises in Switzerland with more rapid and easy channel to access technologies to promote the exchange of knowledge and technology between both parties. Innovation Mentors were professionals retained by the CTI, primarily responsible for evaluating the small-sized and medium-sized enterprises’ need and chance for innovation R&D and helping the enterprises solicit competent academic research partners to engage in the transfer of technology. The third factor of KTT Support, Physical and web-based platforms, is intended to help academic research institutions and private enterprises establish physical liaison channels through organization of activities and installation of network communication platforms, to enable the information about knowledge and technology transfer to be more transparent and communicable widely. In conclusion, the CTI has been dedicated to enhancing the link between scientific research and the industries and urging the industrial sector to involve and boost the R&D projects with market potential. The CTI’s business lines are all equipped with corresponding policy instruments to achieve the industrial-academic cooperation target and mitigate the gap between the industry and academic sectors in the innovation chain. The various CTI policy instruments may be applied in the following manner as identified in the following figure. Data source: CTI Annual Report 2011 Fig. 5 Application of CTI Policy Instrument to Innovation Chain III. Swiss Technology R&D Budget Management and Allocation The Swiss Federal Government has invested considerable expenditures in technology R&D. According to statistic data provided by Swiss Federal Statistical Office (FSO) and OECD, the Swiss research expenditures accounted for 2.37% of the Federal Government’s total expenditures, following the U.S.A. and South Korea (see Fig. 6). Meanwhile, the research expenditures of the Swiss Government grew from CHF2.777 billion in 2000 to CHF4.639 billion in 2010, an average yearly growth rate of 5.9% (see Fig. 7). It is clear that Switzerland highly values its technology R&D. Data source: FSO and OECD Fig. 6 Percentage of Research Expenditures in Various Country Governments’ Total Expenditures (2008) Data source: FSO and OECD Fig. 7 Swiss Government Research Expenditures 2000-2010 1.Management of Swiss Technology R&D Budget Swiss research expenditures are primarily allocated to the education, R&D and innovation areas, and play an important role in the Swiss innovation system. Therefore, a large part of the Swiss research expenditures are allocated to institutions of higher education, including ETH, universities, and UASs. The Swiss research expenditures are utilized by three hierarchies[16] (see Fig. 8): Government R&D funding agencies: The Swiss research budget is primarily executed by three agencies, including SERI, Federal Department of Economic Affairs, Education and Research, and Swiss Agency for Development and Cooperation (SDC). Intermediary R&D funding agencies: Including SNSC and CTI. Funding of R&D performing institutions: Including private enterprises, institutions of higher education and private non-profit-making business, et al. Therefore, the Swiss Government research expenditures may be utilized by the Federal Government directly, or assigned to intermediary agencies, which will allocate the same to the R&D performing institutions. SERI will allocate the research expenditures to institutions of higher education and also hand a lot of the expenditures over to SNSF for consolidated funding to the basic science of R&D. Data source: FSO Fig. 8 Swiss Research Fund Utilization Mechanism ~to be continued~ [1] ORGANIZATION FOR ECONNOMIC CO-OPERATION AND DEVELOPMENT [OECD], OECD Reviews of Innovation Policy: Switzerland 27 (2006). [2] As of January 1, 2013, the Federal Ministry of Economic Affairs was reorganized, and renamed into Federal Department of Economic Affairs, Education and Research (EAER). [3] The Commission for Technology and Innovation CTI, THE COMMISSION FOR TECHOLOGY AND INNOVATION CTI, http://www.kti.admin.ch/org/00079/index.html?lang=en (last visited Jun. 3, 2013). [4] Id. [5] CTI INVEST, Swiss Venture Guide 2012 (2012), at 44, http://www.cti-invest.ch/getattachment/7f901c03-0fe6-43b5-be47-6d05b6b84133/Full-Version.aspx (last visited Jun. 4, 2013). [6] CTI, CTI Activity Report 2012 14 (2013), available at http://www.kti.admin.ch/dokumentation/00077/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDen16fmym162epYbg2c_JjKbNoKSn6A-- (last visited Jun. 3, 2013). [7] CTI Voucher, THE COMMISSION FOR TECHOLOGY AND INNOVATION CTI, http://www.kti.admin.ch/projektfoerderung/00025/00135/index.html?lang=en (last visited Jun. 3, 2013). [8] Id. [9] CTI, CTI Activity Report 2011 20 (2012), available at http://www.kti.admin.ch/dokumentation/00077/index.html?lang=en&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1ad1IZn4Z2qZpnO2Yuq2Z6gpJCDeYR,gWym162epYbg2c_JjKbNoKSn6A--(last visited Jun. 3, 2013). [10] CTI Start-up Brings Science to Market, THE COMMISSION FOR TECHOLOGY AND INNOVATION CTI, http://www.ctistartup.ch/en/about/cti-start-/cti-start-up/ (last visited Jun. 5, 2013). [11] Id. [12] Supra note 8, at 45. [13] Id. [14] CTI Invest, http://www.cti-invest.ch/About/CTI-Invest.aspx (last visited Jun. 5, 2013). [15] KTT Support, CTI, http://www.kti.admin.ch/netzwerke/index.html?lang=en (last visited Jun.5, 2013). [16] Swiss Federal Statistics Office (SFO), Public Funding of Research in Switzerland 2000–2010 (2012), available at http://www.bfs.admin.ch/bfs/portal/en/index/themen/04/22/publ.Document.163273.pdf (last visited Jun. 20, 2013).
Introduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical TrialsIntroduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials 2023/12/15 The development of digital tools such as the internet, apps, and wearable devices have meant major breakthroughs for clinical trials. These advances have the potential to reduce the frequency of trial subject visits, accelerate research timelines, and lower the costs of drug development. The COVID-19 pandemic has further accelerated the use of digital tools, prompting many countries to adopt decentralized measures that enable trial subjects to participate in clinical trials regardless of their physical location. In step with the transition into the post-pandemic era, the Taiwan Food and Drug Administration (TFDA) issued the Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials in June, 2023[1]. The Guidelines are intended to cover a wide array of decentralized measures; they aim to increase trial subjects’ willingness to participate in trials, reduce the need for in-person visits to clinical trial sites, enhance real-time data acquisition during trials, and enable clinic sponsors and contract research organizations to process data remotely. I. Key Points of Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials The Guidelines cover primarily the following matters: General considerations for implementing decentralized measures; trial subject recruitment and electronic informed consent; delivery and provision of investigational medicinal products; remote monitoring of trial subject safety; trial subject reporting of adverse events; remote data monitoring; and information systems and electronic data collection/processing/storage. 1. General Considerations for Implementing Decentralized Measures (1) During clinical trial execution, a reduction in trial subject in-person visits may present challenges to medical observation. It is recommended that home visits for any given trial subject be conducted by the principal investigator, sub-investigator, or a single, consistent delegated study nurse. (2) Sponsors must carefully evaluate all of the trial design’s decentralization measures to ensure data integrity. (3) Sponsors must conduct risk assessments for each individual trial, and must confirm the rationality of choosing decentralized measures. These decentralized measures must also be incorporated into the protocol. (4) When electronically collecting data, sponsors must ensure information system reliability and data security. Artificial intelligence may be considered for use in decentralized clinical trials; sponsors must carefully evaluate such systems, especially when they touch on determinations for critical data or strategies. (5) As the design of decentralized clinical trials is to ensure equal access to healthcare services, it must provide patients with a variety of ways to participate in clinical trials. (6) When implementing any decentralized measures, it is essential to ensure that the principal investigator and sponsor adhere to the Regulations for Good Clinical Practice and bear their respective responsibilities for the trial. (7) The use of decentralized measures must be stated in the regulatory application, and the Checklist of Decentralized Elements in Medicinal Product Clinical Trials must be included in the submission. 2. Subject Recruitment and Electronic Informed Consent (1) Trial subject recruitment through social media or established databases may only be implemented after the Institutional Review Board reviews and approves of the recruitment methods and content. (2) Must comply with the Principles for Recruiting Clinical Trial Subjects in medicinal product trials, the Personal Data Protection Act, and other regulations. (3) Regarding clinical trial subject informed consent done through digital software or devices, if it complies with Article 4, Paragraph 2 of the Electronic Signatures Act, that is, if the content can be displayed in its entirety and continues to be accessible for subsequent reference, then so long as the trial subject agrees to do so, the signature may be done via a tablet or other electronic device. The storage of signed electronic Informed Consent Forms (eICF) must align with the aforementioned Principles and meet the competent authority’s access requirements. 3. Delivery and Provision of Investigational Medicinal Products (1) The method of delivering and providing investigational medicinal products and whether trial subjects can use them on their own at home depends to a high degree on the investigational medicinal product’s administration route and safety profile. (2) When investigational medicinal products are delivered and provided through decentralized measures to trial subjects, this must be documented in the protocol. The process of delivering and providing said products must also be clearly stated in the informed consent form; only after being explained to a trial subject by the trial team, and after the trial subject’s consent is obtained, may such decentralized measures be used. (3) Investigational products prescribed by the principal investigator/sub-investigator must be reviewed by a delegated pharmacist to confirm that the investigational products’ specific items, dosage, duration, total quantity, and labeling align with the trial design. The pharmacist must also review each trial subject’s medication history, to ensure there are no medication-related issues; only then, and only in a manner that ensures the investigational product’s quality and the subject’s privacy, may delegated and specifically-trained trial personnel provide the investigational product to the subject. (4) Compliance with relevant regulations such as the Pharmaceutical Affairs Act, Pharmacists Act, Regulations on Good Practices for Drug Dispensation, and Regulations for Good Clinical Practice is required. 4. Remote Monitoring of Subject Safety (1) Decentralized trial designs involve trial subjects performing relatively large numbers of trial-related procedures at home. The principal investigator must delegate trained, qualified personnel to perform tasks such as collecting blood samples, administering investigational products, conducting safety monitoring, doing adverse event tracking, etc. (2) If trial subjects receive protocol-prescribed testing at nearby medical facilities or laboratories rather than at the original trial site, these locations must be authorized by the trial sponsor and must have relevant laboratory certification; only then may they collect or analyze samples. Such locations must provide detailed records to the principal investigator, to be archived in the trial master file. (3) The trial protocol and schedule must clearly specify which visits must be conducted at the trial site; which can be conducted via phone calls, video calls, or home visits; which tests must be performed at nearby laboratories; and whether trial subjects have multiple or single options at each visit. 5. Subject Reporting of Adverse Events (1) If the trial uses a digital platform to enhance adverse event reporting, trial subjects must be able to report adverse events through the digital platform, such as via a mobile phone app; that is, the principal investigator must be able to immediately access such adverse event information. (2) The principal investigator must handle such reports using risk-based assessment methods. The principal investigator must validate the adverse event reporting platform’s effectiveness, and must develop procedures to identify potential duplicate reports. 6. Remote Data Monitoring (1) If a sponsor chooses to implement remote monitoring, it must perform a reasonability assessment to confirm the appropriateness of such monitoring and establish a remote monitoring plan. (2) The monitoring plan must include monitoring strategies, monitoring personnel responsibilities, monitoring methods, rationale for such implementation, and critical data and processes that must be monitored. It must also generate comprehensive monitoring reports for audit purposes. (3) The sponsor is responsible for ensuring the implementation of remote monitoring, and must conduct risk assessments regarding the implementation process’ data protection and information confidentiality. 7. Information Systems and Electronic Data Collection, Processing, and Storage (1) In accordance with the Regulations for Good Clinical Practice, data recorded in clinical trials must be trustworthy, reliable, and verifiable. (2) It must be ensured that all organizations participating in the clinical trial have a full picture of the data flow. It is recommended that the trial protocol and trial-related documents include data flow diagrams and additional explanations. (3) Define the types and scopes of subject personal data that will be collected, and ensure that every step in the process properly protects their data in accordance with the Personal Data Protection Act. II. A Comparison with Decentralized Trial Regulations in Other Countries Denmark became the first country in the world to release regulatory measures on decentralized trials, issuing the “Danish Medicines Agency’s Guidance on the Implementation of Decentralized Elements in Clinical Trials with Medicinal Products” in September 2021[2]. In December 2022, the European Union as a whole released its “Recommendation Paper on Decentralized Elements in Clinical Trials”[3]. The United States issued the draft “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” document in May 2023[4]. The comparison in Table 1 shows that Taiwan’s guidelines a relatively similar in structure to those of Denmark and the EU; the US guidelines also cover medical device clinical trials. Table 1: Summary of Decentralized Clinical Trial Guidelines in Taiwan, Denmark, the European Union as a whole, and the United States Taiwan Denmark European Union as a whole United States What do the guidelines apply to? Medicinal products Medicinal products Medicinal products Medicinal products and medical devices Trial subject recruitment and electronic informed consent Covers informed consent process; informed consent interview; digital information sheet; trial subject consent form signing; etc. Covers informed consent process; informed consent interview; trial subject consent form signing; etc. Covers informed consent process; informed consent interview; digital information sheet; trial subject consent form signing; etc. Covers informed consent process; informed consent interview; etc. Delivery and provision of investigational medicinal products Delegated, specifically-trained trial personnel deliver and provide investigational medicinal products. The investigator or delegated personnel deliver and provide investigational medicinal products. The investigator, delegated personnel, or a third-party, Good Distribution Practice-compliant logistics provider deliver and provide investigational medicinal products. The principal investigator, delegated personnel, or a distributor deliver and provide investigational products. Remote monitoring of trial subject safety Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories. Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories. Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits. Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories. Trial subject reporting of adverse events Trial subjects may self-report adverse events through a digital platform. Trial subjects may self-report adverse events through a digital platform. Trial subjects may self-report adverse events through a digital platform. Trial subjects may self-report adverse events through a digital platform. Remote data monitoring The sponsor may conduct remote data monitoring. The sponsor may conduct remote data monitoring. The sponsor may conduct remote data monitoring (not permitted in some countries). The sponsor may conduct remote data monitoring. Information systems and electronic data collection, processing, and storage The recorded data must be credible, reliable, and verifiable. Requires an information system that is validated, secure, and user-friendly. The recorded data must be credible, reliable, and verifiable. Must ensure data reliability, security, privacy, and confidentiality. III. Conclusion The implementation of decentralized clinical trials must be approached with careful assessment of risks and rationality, with trial subject safety, rights, and well-being as top priorities. Since Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials were just announced in June of this year, the status of decentralized clinical trial implementation is still pending industry feedback to confirm feasibility. The overall goal is to enhance and optimize the clinical trial environment in Taiwan. Reference: [1] 衛生福利部食品藥物管理署,〈藥品臨床試驗執行分散式措施指引〉,2023/6/12,https://www.fda.gov.tw/TC/siteListContent.aspx?sid=9354&id=43548(最後瀏覽日:2023/11/2)。 [2] [DMA] DANISH MEDICINES AGENCY, The Danish Medicines Agency’s guidance on the Implementation of decentralised elements in clinical trials with medicinal products (2021),https://laegemiddelstyrelsen.dk/en/news/2021/guidance-on-the-implementation-of-decentralised-elements-in-clinical-trials-with-medicinal-products-is-now-available/ (last visited Nov. 2, 2023). [3] [HMA] HEADS OF MEDICINES AGENCIES, [EC] EUROPEAN COMMISSION & [EMA] EUROPEAN MEDICINES AGENCY, Recommendation paper on decentralised elements in clinical trials (2022),https://health.ec.europa.eu/latest-updates/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en (last visited Nov. 2, 2023). [4] [US FDA] US FOOD AND DRUG ADMINISTRATION, Decentralized Clinical Trials for Drugs, Biological Products, and Devices (draft, 2023),https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices (last visited Nov. 2, 2023).