<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="research-article" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.160332.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Research Article</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Ideal Approaches to AI Regulation in LATAM Countries: Promoting Technological Advancement and Human Rights Protections</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: 2 approved with reservations]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Dunayevich</surname>
                        <given-names>Enzo</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0009-0002-6754-9586</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Akiyama</surname>
                        <given-names>Hajime</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-2251-8324</uri>
                    <xref ref-type="aff" rid="a2">2</xref>
                    <xref ref-type="aff" rid="a3">3</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Doctoral Program in International Public Policy, Graduate School of Business Sciences, Humanities and Social Sciences, University of Tsukuba, Tsukuba, Ibaraki, 305-8571, Japan</aff>
                <aff id="a2">
                    <label>2</label>Institute of Humanities and Social Sciences, University of Tsukuba, Tsukuba, Ibaraki, 305-8571, Japan</aff>
                <aff id="a3">
                    <label>3</label>Center for Artificial Intelligence Research, University of Tsukuba, Tsukuba, Ibaraki, 305-8577, Japan</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:dunayevich.enzo@gmail.com">dunayevich.enzo@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>17</day>
                <month>3</month>
                <year>2025</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2025</year>
            </pub-date>
            <volume>14</volume>
            <elocation-id>305</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>24</day>
                    <month>2</month>
                    <year>2025</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Dunayevich E and Akiyama H</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/14-305/pdf"/>
            <abstract>
                <sec>
                    <title>Background</title>
                    <p>Today&#x2019;s approaches to regulating AI diverge from countries and regions. For instance, Japan&#x2019;s framework emphasizes agile governance, relying on soft law, corporate cooperation, and a deregulatory approach. In contrast, the EU adopts a hard law model with a risk-based approach centered on protecting human rights. Discussing the benefits and downsides of each will be deemed valuable for LATAM&#x2019;s journey to regulating AI.</p>
                </sec>
                <sec>
                    <title>Methods</title>
                    <p>The authors identified guidelines and laws from Japan and the European Union by searching official websites and Google Scholar through 2023 and 2024. We divided the search between both researchers, one of us in charge of the Japanese documents and the other of the EU and Latin America ones. The relevant documents were selected when containing soft laws, hard laws, and independent reports about AI. The authors then proceeded to conduct a document analysis of the current situation in the LATAM region as well as a comparison between the Japanese and EU approaches to AI. Through this process, the logic behind each approach was deduced and then evaluated for suitability for the LATAM region.</p>
                </sec>
                <sec>
                    <title>Results</title>
                    <p>LATAM faces unique challenges in regulating AI. Limited investment in innovation and research, along with insufficient venture capital, places the region below global averages in technological development. Overly restrictive regulations risk worsening this disparity. A Japanese approach appears more convenient for the region rather than a European one. In this realm, it is crucial to avoid a binary logic that positions technological growth and human rights protection as opposing objectives.</p>
                </sec>
                <sec>
                    <title>Conclusions</title>
                    <p>The study proposes five principles for future AI regulation in LATAM: fostering innovation, balancing risks, and benefits, tailoring frameworks to regional needs, avoiding restrictive measures, and incorporating both Western and Asian perspectives. Ultimately, this study underscores the importance of context-specific, balanced regulations that address LATAM&#x2019;s unique challenges and opportunities in AI governance.</p>
                </sec>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Artificial intelligence</kwd>
                <kwd>Latin America</kwd>
                <kwd>AI</kwd>
                <kwd>LATAM</kwd>
                <kwd>AI regulations</kwd>
                <kwd>AI and human rights</kwd>
                <kwd>AI and technological advancement</kwd>
            </kwd-group>
            <funding-group>
                <award-group id="fund-1" xlink:href="https://doi.org/10.13039/501100006559">
                    <funding-source>University of Tsukuba</funding-source>
                </award-group>
                <award-group id="fund-2">
                    <funding-source>Kumagai Gumi Co.,Ltd.</funding-source>
                </award-group>
                <funding-statement>This paper was supported by Kumagai Gumi Co.,Ltd. and University of Tsukuba.</funding-statement>
                <funding-statement>
                    <italic>The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</italic>
                </funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec5" sec-type="intro">
            <title>1. Introduction</title>
            <p>The rapid and uncertain evolution of artificial intelligence (AI) has brought both promising technological advancements and significant concerns related to security, privacy, and crime. This dichotomy is often referred to as the dual nature of AI.
                <xref ref-type="fn" rid="fn1">
                    <sup>1</sup>
                </xref> In response, governments across Asia, North America, and Europe have taken steps to regulate AI, seeking to harness its benefits while mitigating risks to human rights. However, in the global pursuit to govern legislate AI, many developing countries in the Global South, especially in Latin America (LATAM), are still in the initial steps.</p>
            <p>Failing to properly leverage the benefits of AI threatens to exacerbate the developmental and technological disparities between the LATAM region and the leading economies. Consequently, a thoughtful examination of a potential LATAM approach to AI becomes imperative for ensuring the continued development of these countries in the era of cutting-edge digital technology.</p>
            <p>Although it is necessary to explore how the LATAM region should deal with AI, such exploration is still neglected in the academic literature. Research has compared ongoing regulatory efforts in different LATAM countries, but these lack a comparison with Asian and European policies, specifically the approaches of Japan and the European Union (EU).
                <xref ref-type="fn" rid="fn2">
                    <sup>2</sup>
                </xref> A comparison along these lines could provide valuable benefits by elucidating different motivations, objectives, and concerns, which could then be leveraged by LATAM policymakers.</p>
            <p>Based on the above, the article investigates the most suitable approach to AI regulation in Latin American countries considering the region&#x2019;s particular needs. The paper employs a qualitative methodology through a legal comparison method. Because it is meaningful to refer to the position of the EU and Japan, this article analyzes and compares the policies and regulations of the EU and Japan to elucidate the advantages and pitfalls of each framework.
                <xref ref-type="fn" rid="fn3">
                    <sup>3</sup>
                </xref> The article elaborates on the relationship between technology and human rights, providing a nuanced understanding of LATAM&#x2019;s developmental needs to determine a suitable regulation type for the region.</p>
            <p>The article first discusses the current situation of AI regulation in LATAM, discussing the development and technology gap in the region. Next, it addresses the EU&#x2019;s approach to AI, which relies on hard law to protect human rights, and the Japanese framework, which implements soft law to foster the promotion of technology. This elicits a discussion of the relationship between technology and human rights, drawing attention to the dual nature of technology and its potential to affect and enhance human rights. Finally, reflecting on the previous sections, the paper concludes by suggesting the best approach to regulating AI in the LATAM region.</p>
            <sec id="sec6">
                <title>1.1 Methods</title>
                <p>The authors identified guidelines and laws from Japan and the European Union by searching official websites and Google Scholar through 2023 and 2024. We divided the search between both researchers, one of us in charge of the Japanese documents and the other of the EU and Latin America ones. Regarding the EU AI act, a continuous revision of updates was required given the Act&#x2019;s approval process at the time of writing this paper. The relevant documents were selected when containing soft laws (guidelines), hard laws, and independent reports about AI. The authors then proceeded to conduct a document analysis of the current situation in the LATAM region as well as a comparison between the Japanese and EU approaches to AI. Through this process, the logic behind each approach was deduced and then evaluated for suitability for the LATAM region. This includes a discussion on both the benefits and downsides of frameworks that legislate the relationship between human rights protection and technology promotion.</p>
            </sec>
            <sec id="sec7">
                <title>1.2 Results</title>
                <p>The comparison of the Japanese and EU approaches suggests that a flexible, &#x201c;soft law&#x201d; framework might be better for the LATAM region. However, this approach must avoid a binary logic that frames technology promotion and human rights protection as conflicting objectives. The region must adopt a nuanced, context-sensitive framework that incorporates perspectives from both Western and Asian models. To this end, the study proposes five principles for regulating AI in LATAM: prioritizing innovation, balancing risks with benefits, addressing regional disparities, ensuring equitable technological growth, and protecting human rights.</p>
            </sec>
        </sec>
        <sec id="sec8">
            <title>2. AI in LATAM: The development gap and widening disparities</title>
            <p>In LATAM, efforts toward the governance of AI are still at the initial stages, characterized by inequality from country to country. A key development, however, was made in 2023 at the Forum for Ethics of Artificial Intelligence in LATAM and the Caribbean.
                <xref ref-type="fn" rid="fn4">
                    <sup>4</sup>
                </xref> Here, twenty LATAM and Caribbean countries collectively discussed their initiatives concerning AI regulation, leading to the signing of the Santiago Declaration. This declaration emphasizes the need for countries in these neighboring regions to work cooperatively to harness the benefits and mitigate the risks of AI technologies. It recognizes the importance of integrating the particularities of the LATAM and Caribbean regions when creating and utilizing AI technologies, emphasizing the respect of human rights when evaluating AI policies. Paragraph 6 recognizes the instrumental value of technologies for the full enjoyment of human rights, especially among vulnerable groups.
                <xref ref-type="fn" rid="fn5">
                    <sup>5</sup>
                </xref>
            </p>
            <p>At the national level, Chile has emerged as a frontrunner in AI regulation, showcasing significant accomplishments. Colombia has also established a robust ethical framework for AI, while Mexico concentrates on bolstering privacy rights. In 2023, Argentina approved the &#x201c;Recommendations for a Trustworthy AI.&#x201d;
                <xref ref-type="fn" rid="fn6">
                    <sup>6</sup>
                </xref> Notably, a recent LATAM feminist forum on AI highlighted diverse perspectives, where the Delegate of Uruguay shared ongoing concerns about regulating AI to balance innovation and protect human rights.
                <xref ref-type="fn" rid="fn7">
                    <sup>7</sup>
                </xref> Peru has enacted legislation emphasizing the importance of individuals and human rights in AI use.
                <xref ref-type="fn" rid="fn8">
                    <sup>8</sup>
                </xref> Meanwhile, Venezuela is in the process of drafting a bill addressing data protection.
                <xref ref-type="fn" rid="fn9">
                    <sup>9</sup>
                </xref>
            </p>
            <p>Despite such efforts, data from Oxford Insights illustrate that the LATAM region is still far behind the major countries&#x2019; approaches. The 
                <italic toggle="yes">Oxford AI Readiness Index 2023</italic> measures the readiness of 193 countries to implement AI in the delivery of public services. It employs 39 indicators to analyze the government, technology sector, and data infrastructure of a given country.
                <xref ref-type="fn" rid="fn10">
                    <sup>10</sup>
                </xref> National results concerning LATAM and Caribbean countries demonstrated a substantial difference in close to forty points from the United States of America (USA), the 
                <italic toggle="yes">Index</italic>&#x2019;s leader. Regionally, LATAM ranks sixth out of nine places, behind North America, Europe, East Asia, the Middle East, and North Africa.</p>
            <p>While &#x201c;four of the five&#x201d; leading LATAM countries&#x2014;Brazil, Chile, Uruguay, and Colombia&#x2014;were &#x201c;within the global top 40&#x201d; in governmental capacity, the 
                <italic toggle="yes">Index</italic> found that overall, the region &#x201c;seems to be lagging in the Innovation Capacity dimension &#x2026; where we find a gap of almost 10 points between the regional and global average.&#x201d;
                <xref ref-type="fn" rid="fn11">
                    <sup>11</sup>
                </xref> Here, &#x201c;Innovation Capacity&#x201d; indicates whether a country&#x2019;s technology sector has the conditions required to support innovation. It comprises five indicators measuring the time spent dealing with government regulations, venture capital (VC) availability, research and development (R&amp;D) spending, company investment in emerging technology, and published papers on AI research. As pointed out by Oxford Insights, when the technology sector lacks strength, countries might begin to rely on foreign AI systems.
                <xref ref-type="fn" rid="fn12">
                    <sup>12</sup>
                </xref> This may deter the development of domestic technology sectors and ignore the particularities of LATAM countries as such AI systems are trained with foreign data.</p>
            <p>The results from the 
                <italic toggle="yes">Index</italic> thus demonstrate the gap between LATAM&#x2019;s technology sector and those of the major world economies. It suggests that AI regulations in the region should pay more attention to this gap and focus on strengthening domestic technological investment and research while considering the potential for innovation and human development. Moreover, failing to leverage the benefits of AI could potentially expand the development gap between LATAM and high-income countries. In fact, before COVID-19, the region was already experiencing growing poverty rates, and the downturn of the region&#x2019;s major economies (such as in Peru) became a more significant issue. The recent pandemic precipitated even more serious struggles in LATAM, which in one year lost the equivalent of 30% of its progress since 1990 and became the region most damaged by the pandemic.
                <xref ref-type="fn" rid="fn13">
                    <sup>13</sup>
                </xref>
            </p>
            <p>This fact is of extreme importance considering the ongoing development gap between LATAM and high-income countries. According to the 
                <italic toggle="yes">World Inequality Report</italic> (2022), the world is marked by a high level of income inequality and an extreme level of wealth inequality both within and between countries. The inequalities between countries have reached their peak; in 2021, LATAM owned only 51% of the average global wealth compared to 142% of East Asia, 230% of Europe and 390% in North America. Additionally, compared to 36% in Europe, the top 10% of LATAM&#x2019;s population owns 55% of the national income, while the bottom 50% earns 27 times less than the top 10%.Conversely, in Europe, the value is only 9 times less. For instance, in Brazil, one of the LATAM countries with better prospects, the bottom 50% earns 29 times less than the top 10%, while in France the difference is only seven times less.</p>
            <p>Leaders in LATAM have already recognized the need to regulate AI, considering the potential of these technologies for both enhancing and damaging human rights. The Santiago Declaration and national efforts are commendable. However, the region still needs to move from declarations to effective policies. To this end, it is crucial to consider the need to reduce the development and technology gap between LATAM and other major world economies. AI technologies could play a key role in this regard. To this end, the frameworks established by the EU and Japan provide useful models for potential ways forward.</p>
        </sec>
        <sec id="sec9">
            <title>3. The EU approach: Hard law for human rights protections</title>
            <p>The EU approach to AI is characterized as &#x201c;holistic and hard-law-based.&#x201d;
                <xref ref-type="fn" rid="fn14">
                    <sup>14</sup>
                </xref> EU efforts to regulate AI can be traced to its resolutions about robotics in 2017. The Civil Law Rules on Robotics is one of the first adopted resolutions addressing AI.
                <xref ref-type="fn" rid="fn15">
                    <sup>15</sup>
                </xref> While it certainly acknowledges the importance of technology to promote innovation, it focuses more on major safety concerns and the protection of human rights. For instance, its introduction states the need for AI development to &#x201c;preserve the dignity, autonomy, and self-determination of the individual.&#x201d;
                <xref ref-type="fn" rid="fn16">
                    <sup>16</sup>
                </xref> Its articles further address the social, ethical, legal, and economic concerns about AI. Article 10, for example, mentions some of the stakes at risk when using robotics, including health, freedom, privacy, integrity, dignity, self-determination, and non-discrimination. Article 13 reviews the relevant principles and values set forth by Article 2 of the Treaty of the European Union, the Charter of Fundamental Rights, and the Union Law, pointing out that all future policies should comply with these instruments. In particular, it emphasizes human dignity, equality, justice, equity, transparency, and individual and social responsibility. Article 19 adds the principles of necessity and proportionality, and Articles 20 and 43 emphasize the necessity of addressing robotics-related job loss. Overall, the resolution suggests that its focus on human rights is in part to protect the EU&#x2019;s aging population, showing concerns about the potential harmful uses of technology, such as job replacement and the impact of algorithms on people&#x2019;s choices.
                <xref ref-type="fn" rid="fn17">
                    <sup>17</sup>
                </xref> This is a crucial early position of the EU&#x2019;s approach to AI regulation, as its influence on the later European Union AI Act (hereafter called the EU AI Act) is obvious.</p>
            <p>The EU AI Act highlights the same rights and principles as the Civil Law on Robotics and elaborates on the harmful uses of AI systems. The act was first proposed in 2021.
                <xref ref-type="fn" rid="fn18">
                    <sup>18</sup>
                </xref> It was finally approved and published in the 
                <italic toggle="yes">
European Official Journal</italic> on July 12, 2024, entering into force on the August 2.
                <xref ref-type="fn" rid="fn19">
                    <sup>19</sup>
                </xref> It faced several debates and significant lobbying from major tech companies that significantly delayed its approval, which had originally been expected by 2023.</p>
            <p>The EU AI Act presents a risk-based approach with different levels of compliance burdens on AI producers and users, in line with EU values and fundamental rights. Categorizing the threats as minimal risk, limited risk, high risk, and unacceptable risk, the approach aims to mitigate the threats to fundamental rights and guarantee the safety of AI systems.
                <xref ref-type="fn" rid="fn20">
                    <sup>20</sup>
                </xref> Regarding unacceptable risk, Article 5 in Chapter II of the EU AI Act explicitly prohibits AI systems that constitute a direct and unacceptable threat to individuals.
                <xref ref-type="fn" rid="fn21">
                    <sup>21</sup>
                </xref> Here, &#x201c;unacceptable risk&#x201d; includes cognitive behavioral manipulation targeting people or vulnerable groups, such as voice-activated toys that encourage dangerous behavior in children. Additionally, social scoring methods that classify individuals based on behavior, socioeconomic status, or personal characteristics are deemed unacceptable. The prohibition extends to using biometric identification for the categorization of individuals, as well as to real-time and remote biometric identification systems like facial recognition.</p>
            <p>Furthermore, the high-risk category comprises AI systems that have a negative impact on safety or fundamental rights. These threats are classified into two groups: first, those integrated into products falling under the EU&#x2019;s product safety legislation, covering diverse items like toys, aviation, cars, medical devices, and elevators. The second group includes AI systems that fall within specific critical areas including the management and operation of critical infrastructure, education, employment, access to essential services, law enforcement, migration and border control, and legal interpretation.
                <xref ref-type="fn" rid="fn22">
                    <sup>22</sup>
                </xref>
            </p>
            <p>This risk-based approach responds to four objectives, as explained in the proposal&#x2019;s explanatory memorandum:
                <list list-type="bullet">
                    <list-item>
                        <label>&#x25aa;</label>
                        <p>ensure that AI systems placed on the Union market and used are safe and respect existing law on fundamental rights and Union values;</p>
                    </list-item>
                    <list-item>
                        <label>&#x25aa;</label>
                        <p>ensure legal certainty to facilitate investment and innovation in AI;</p>
                    </list-item>
                    <list-item>
                        <label>&#x25aa;</label>
                        <p>enhance governance and effective enforcement of existing law on fundamental rights and safety requirements applicable to AI systems;</p>
                    </list-item>
                    <list-item>
                        <label>&#x25aa;</label>
                        <p>Facilitate the development of a single market for lawful, safe, and trustworthy AI applications and prevent market fragmentation.
                            <xref ref-type="fn" rid="fn23">
                                <sup>23</sup>
                            </xref>
                        </p>
                    </list-item>
                </list>
            </p>
            <p>To achieve these four objectives, the EU AI Act was proposed as the proportional, necessary, and most effective policy instrument.
                <xref ref-type="fn" rid="fn24">
                    <sup>24</sup>
                </xref> It covers every AI system and user within the EU market (Article 2: Scope). It also provides explicit enforcement measures (Section 3) and penalties (Chapter XII). Moreover, it is a generalist regulation that does not limit its scope to a specific sector, but rather covers every application, user, and provider of an AI system.
                <xref ref-type="fn" rid="fn25">
                    <sup>25</sup>
                </xref>
            </p>
            <p>Notably, the concern to secure fundamental rights lies at the core of the risk-based approach. In fact, the proposal&#x2019;s principal text mentions the phrase &#x201c;fundamental rights&#x201d; 81 times. Furthermore, two of the four above objectives emphasize the respect and effective enforcement of the existing law on &#x201c;fundamental rights.&#x201d;
                <xref ref-type="fn" rid="fn26">
                    <sup>26</sup>
                </xref> Additionally, the proposal stresses the improvement of fundamental rights protection when explaining the reasons for adopting a regulation in the form of a legal instrument.
                <xref ref-type="fn" rid="fn27">
                    <sup>27</sup>
                </xref> In particular, it expressly lists rights referring to the EU Charter of Fundamental Rights. These rights include the right to human dignity (Article 1), privacy and the protection of personal data (Articles 7 and 8), non-discrimination (Article 21), equality between women and men (Article 23), as well as an effective remedy, a fair trial, defense, and the presumption of innocence (Articles 47 and 48). Additionally, the proposal expresses its intention to prevent a so-called &#x201c;chilling effect&#x201d; on the rights to the freedom of expression (Article 11) and the freedom of assembly (Article 12).
                <xref ref-type="fn" rid="fn28">
                    <sup>28</sup>
                </xref> The proposal also covers workers&#x2019; rights to fair and just working conditions (Article 31), consumer protection (Article 28), the rights of the child (Article 24), and the integration of persons with disabilities (Article 26). Finally, it covers the right to a high level of environmental protection and the improvement of the environment&#x2019;s quality (Article 37) in relation to health and safety obligations.</p>
            <p>This comprehensive overview illustrates the EU&#x2019;s focus on human rights when regulating AI. The proposal names this approach &#x201c;Responsible innovation,&#x201d; alleging that restrictions to the rights of freedom to conduct business (Article 16) and the freedom of art and science (Article 13) are proportionate and restricted to the minimum necessary to tackle high-risk AI technology development and use.
                <xref ref-type="fn" rid="fn29">
                    <sup>29</sup>
                </xref>
            </p>
            <p>It is important to note, however, that nowhere does the EU AI Act proposal fully explain the reasons it considers the risk-based approach proportionate and necessary. Only Section 2.3 argues that the &#x201c;a risk-based approach&#x201d; is &#x201c;proportional and necessary.&#x201d;
                <xref ref-type="fn" rid="fn30">
                    <sup>30</sup>
                </xref> Additionally, according to Section 3.3, different policy options were considered against economic and societal impacts while keeping the overall focus on potential impacts to fundamental human rights. However, the risk-based approach was chosen as the most effective means of achieving the four objectives.
                <xref ref-type="fn" rid="fn31">
                    <sup>31</sup>
                </xref> Nevertheless, some legal scholars have already voiced uncertainties about the approach.
                <xref ref-type="fn" rid="fn32">
                    <sup>32</sup>
                </xref>
            </p>
            <p>Some questions remain. First, why can&#x2019;t alternative policy options achieve the objectives outlined in the proposal? Put differently, why were other policy choices deemed to be likely to fail to protect human rights or be unable to protect them as effectively as a hard law, risk-based approach? Second, is there any hierarchy between the four objectives of the risk-based approach?
                <xref ref-type="fn" rid="fn33">
                    <sup>33</sup>
                </xref> This is a crucial matter given that a focus on safeguarding fundamental rights explains the strictness of the risk-based approach. More precision on these aspects could have clarified whether the EU AI Act was truly the optimal policy choice.</p>
        </sec>
        <sec id="sec10">
            <title>4. The Japanese approach: Soft law for technology promotion</title>
            <p>The Japanese approach is regarded as &#x201c;sector-specific and soft-law-based.&#x201d;
                <xref ref-type="fn" rid="fn34">
                    <sup>34</sup>
                </xref> One feature that is different from the European approach is the attempt to assure that technology, including AI, has a positive impact on society. As of February 2024, there is no statute that holistically regulates the development and use of AI in Japan. The Japanese stance is indicated in the report prepared by the Expert Group on How AI Principles Should be Implemented, which was initiated by the Ministry of Economy, Trade and Industry (METI) in 2021. This report notes that AI innovation and development are rapid and complex, so it is difficult for laws and regulations to keep up. As a result, rule-based regulation that attempts to strictly regulate the actions of innovators can hinder innovation. In such circumstances, rule-based governance is not appropriate, and a goal-based approach &#x201c;that can guide entities such as companies to the value to be attained&#x201d; is preferable.
                <xref ref-type="fn" rid="fn35">
                    <sup>35</sup>
                </xref> As a result, the report claims that instead of regulating on the basis of legislation, &#x201c;an intermediate rule like a guideline with multi-stakeholders&#x201d; should be set.
                <xref ref-type="fn" rid="fn36">
                    <sup>36</sup>
                </xref>
            </p>
            <p>One important relevant concept in the Japanese stance is that of agile governance, which was mentioned in the report of the Study Group on New Governance Models in Society 5.0, established by the METI in 2021. In Japan, AI governance is a part of the governance of &#x201c;&#x2018;Society 5.0,&#x2019; which is a human-centered society where high integration of cyberspace and physical space can promote economic development and solve social issues.&#x201d;
                <xref ref-type="fn" rid="fn37">
                    <sup>37</sup>
                </xref> Changes in Society 5.0 are rapid and difficult to predict.
                <xref ref-type="fn" rid="fn38">
                    <sup>38</sup>
                </xref> In such circumstances, traditional approaches to laws and regulations, which emphasize the government&#x2019;s role in regulating private actors through various enforcement mechanisms, face considerable challenges.
                <xref ref-type="fn" rid="fn39">
                    <sup>39</sup>
                </xref> In this context, agile governance is proposed as a more appropriate alternative. Agile governance has multi-layered features, and both governments and corporations have roles to play.
                <xref ref-type="fn" rid="fn40">
                    <sup>40</sup>
                </xref> Thus, the government does not make laws and regulations based on a traditional rule-based approach, and the corporation&#x2019;s voluntary activities are emphasized.
                <xref ref-type="fn" rid="fn41">
                    <sup>41</sup>
                </xref>
            </p>
            <p>Instead, agile governance provides principles and guidelines that are not legally binding. Along these lines, the Cabinet Office issued 
                <italic toggle="yes">Social Principles of Human-Centric AI</italic> in 2019, which highlighted the following principles: human-centric, education/literacy, privacy protection, ensuring security, fair competition, fairness, accountability, transparency, and innovation.
                <xref ref-type="fn" rid="fn42">
                    <sup>42</sup>
                </xref> These are in line with the basic principles guiding the current Japanese government. Meanwhile, 
                <italic toggle="yes">Governance Guidelines for Implementation of AI Principles</italic> was published in 2022. These general guidelines mandate that corporations that develop and operate AI systems are expected to prepare the goals of AI governance.
                <xref ref-type="fn" rid="fn43">
                    <sup>43</sup>
                </xref> More specific regulations in Japan include the Digital Platform Transparency Act, the Financial Instruments and Exchange Act, the Act on the Protection of Personal Information, the Road Traffic Act, the Road Transport Vehicle Act, the Installment Sales Act, the High Pressure Gas Safety Act, the Copyright Act, and the Unfair Competition Prevention Act.
                <xref ref-type="fn" rid="fn44">
                    <sup>44</sup>
                </xref>
            </p>
            <p>Based on the above, some corporations have developed their own guidelines. For instance, Sony created 
                <italic toggle="yes">Sony Group AI Ethics Guidelines</italic> in 2018 and updated them in 2021. These guidelines are based on eight principles: supporting creative lifestyles and building a better society, stakeholder engagement, the provision of trusted products and services, privacy protection, respect for fairness, the pursuit of transparency, the evolution of AI, and ongoing education.
                <xref ref-type="fn" rid="fn45">
                    <sup>45</sup>
                </xref> Similarly, NEC Corporation enacted the 
                <italic toggle="yes">NEC Group AI and Human Rights Principles</italic> in 2019. These principles include fairness, privacy, transparency, the responsibility to explain, proper utilization, AI and talent development, and dialogue with multiple stakeholders.
                <xref ref-type="fn" rid="fn46">
                    <sup>46</sup>
                </xref> Fujitsu Limited also developed the 
                <italic toggle="yes">Fujitsu Group AI Commitment</italic> in the same year, which strive for the provision of value to customers and society with AI, the creation of human-centric AI, a sustainable society with AI, and AI that respects and supports people&#x2019;s decision making as part of its corporate responsibility, emphasizing transparency and accountability in AI implementation.
                <xref ref-type="fn" rid="fn47">
                    <sup>47</sup>
                </xref>
            </p>
            <p>The above corporate principles and guidelines were all prepared before the 
                <italic toggle="yes">Governance Guidelines for Implementation of AI Principles</italic> were published in 2022. Other corporations have since established their own guidelines and principles in response. In 2022, for example, Panasonic established the 
                <italic toggle="yes">Panasonic Group AI Ethics Principles</italic>, which include creating a better life and society, prioritizing safety, respecting human rights and fairness, transparency and accountability, and protecting customers&#x2019; privacy. 
                <xref ref-type="fn" rid="fn48">
                    <sup>48</sup>
                </xref> In 2023, Epson prepared the 
                <italic toggle="yes">Epson Group AI Ethical Principles</italic>, which promote the coexistence of humans and AI and creating new value through collaboration, accountability, safe and secure data distribution, and responsible development.
                <xref ref-type="fn" rid="fn49">
                    <sup>49</sup>
                </xref>
            </p>
            <p>Many of these principles discuss the relationship between humans and AI. This indicates that companies that develop and operate AI do not only focus on the technological development of AI but emphasize its relationship with humans. Many of them also mention social values such as fairness, accountability, and sustainability. It is also interesting that there are a variety of foci for each corporation. Some mention the importance of collaborating with other stakeholders, others discuss education, and some call for the spread of responsible AI. This indicates that overall consistency between the corporation&#x2019;s principles alongside the unique foci of each corporation.</p>
            <p>There are some issues worth noting in the Japanese approach. The first is the context. In Japan, the governance of AI is discussed in the context of science and technology policymaking, and this is what influences the nature of the Japanese stance toward AI governance. As noted above, Japanese AI governance is dictated by Society 5.0, a concept proposed by the Japanese government&#x2019;s 5
                <sup>th</sup> Science and Technology Basic Plan, which indicates places AI governance within the science and technology sector. Furthermore, the METI, which deals with Japanese industry, covers the issues of AI. So long as AI governance is considered solely within the context of science and technology, it is it is likely that the Japanese approach will continue to focus on the promotion of technology. If, for example, the Japanese Human Rights Bureau initiates the creation of AI guidelines, its approach could be different.
                <xref ref-type="fn" rid="fn50">
                    <sup>50</sup>
                </xref>
            </p>
            <p>Another issue with the current system from a practical perspective of the current system is the possibility of limited commitment by corporations. Even if it is true that multiple actors need to seriously consider their approaches to AI, the current Japanese stance pursuant to the 
                <italic toggle="yes">Governance Guidelines for Implementation of AI Principles</italic> is that corporations need to develop goal-based principles 
                <italic toggle="yes">if necessary</italic>, but that they can merely follow the 
                <italic toggle="yes">Social Principles of Human-Centric AI</italic> prepared by the Cabinet Office. In this case, corporations do not have to work on AI governance if they do not have much commitment to it. This could create future problems.</p>
            <p>The Japanese approach may change with time. For instance, some Diet members from the Liberal Democratic Party, the current ruling party, claim that the guidelines on AI need to be legislated.
                <xref ref-type="fn" rid="fn51">
                    <sup>51</sup>
                </xref> The Minister of State for Science and Technology Policy, Takaichi Sanae, has stated that the Cabinet Office needs to further research the legislation of other states on the subject.
                <xref ref-type="fn" rid="fn52">
                    <sup>52</sup>
                </xref> With the EU&#x2019;s legislation of the AI Act, there is a possibility that the necessity of legislation is discussed in Japan.</p>
        </sec>
        <sec id="sec11">
            <title>5. Human rights protection and technology promotion in Japan and the EU</title>
            <p>In AI governance, it is essential to understand and be aware of the issues related to both technology and human rights. Technology can be used to violate human rights, but also to promote them. Hence, the need for balance and contextual limitations is necessary. An overprotective framework may stiffen innovation, preventing countries from achieving potential growth, while an extremely permissive one may pose intolerable risks to human rights.</p>
            <p>As stated by the 
                <italic toggle="yes">Human Development Report</italic>, technological advances within proper risk management can lead to an increase in people&#x2019;s capabilities and agency.
                <xref ref-type="fn" rid="fn53">
                    <sup>53</sup>
                </xref> Indeed, technological progress can enable access to education, healthcare, and financial services, among others, increasing choices and potentially improving quality of life. From a utilitarian perspective, technology plays a crucial role in facilitating the promotion of human rights. AI can assist with image recognition and gathering data on rights abuses. For instance, this might include performing analyses of geospatial images to detect mass human rights violations in remote regions or contamination analysis of soil and water to determine the human rights impacts of mining activities.
                <xref ref-type="fn" rid="fn54">
                    <sup>54</sup>
                </xref> Additionally, nations can utilize satellite information to monitor displaced populations, and forensic technology supports law enforcement agencies in reconstructing crime scenes and ensuring accountability for perpetrators.</p>
            <p>However, while emerging technologies offer myriad benefits for human rights, they also harbor potential risks. Authoritarian regimes employ surveillance tools to monitor dissidents and vulnerable populations, and the proliferation of &#x201c;deepfakes&#x201d; threatens democratic processes and women&#x2019;s rights. Moreover, as Land and Arison point out, using technology to protect human rights requires evaluating the equitable distribution of a given technology, as underlying conditions play a crucial role in the accessibility of technology to every individual.
                <xref ref-type="fn" rid="fn55">
                    <sup>55</sup>
                </xref> For instance, prepaid water meter technology in South Africa has faced serious criticism regarding preventing access to water for the poor or those without access, suggesting that technology can produce more harm if applied without considering social imbalances.
                <xref ref-type="fn" rid="fn56">
                    <sup>56</sup>
                </xref> Hence, a policy that promotes innovation in the use of technology for enhancing human rights simultaneously requires awareness of the risks that technology poses violate human rights and make efforts toward equal access.</p>
            <p>The European Union AI Act, as stated earlier, is considered an instrument that places strict restrictions on AI to protect the freedoms to conduct business and of art and science, calling this approach a responsible innovation. Nevertheless, the act faced serious delays due to concerns about unnecessary restrictions on technological progress, suggesting that it might not be as balanced as alleged. Indeed, representatives from various companies in the EU addressed an open letter to the European Commission, the European Council, and the European Parliament in July 2023. Signed by representatives from 150 businesses, including Siemens in Germany and Airbus in France, the letter criticized the ineffectiveness and bureaucratic approach of the EU AI Act. The letter called for a broad, principled, and risk-based approach rather than a rigid one, raising concerns about the act&#x2019;s potential to jeopardize Europe&#x2019;s competitiveness and technological sovereignty. According to the letter&#x2019;s reasoning, an eventual approval of the act would lead to important compliance costs for European companies, forcing them to move their activities outside the Union.
                <xref ref-type="fn" rid="fn57">
                    <sup>57</sup>
                </xref> The European Tech Alliance takes a similar position. In their November 2023 statement, this organization of 30 leading European tech companies stated that current EU regulations could demand up to 30% of EU tech companies&#x2019; resources in compliance.
                <xref ref-type="fn" rid="fn58">
                    <sup>58</sup>
                </xref>
            </p>
            <p>Furthermore, although the European Union approach refers to its proposal as a balance between innovation, technology, and human rights, this is only one side of the coin. While it ensures the protection of human rights from harmful uses of technology, the proposal might not comprehensively consider the potential of AI technologies to further the enjoyment of human rights. The risk-based approach in act suggests a stronger concern about AI&#x2019;s threats to human rights than the possibility of enhancing them. In this sense, the act pays excessive attention to AI&#x2019;s negative effects and fails to properly consider its positive potential. An excessive focus on such negative aspects generates a negative view of technology as a whole, which could delay the use of cutting-edge technology to enhance human rights.</p>
            <p>Like the European position, the Japanese approach also centers humanity at the core of their regulations. However, the key difference lies in how they choose to leverage the benefits of AI for human rights. While the regulations can be regarded as a weak, AI moves in a fast-paced environment and massive changes can occur within a year or even just a few months. Hard law regulations in this realm may be inadequate to keep up with these changes, and the Japanese concept of agile governance might be more effective for such a context.</p>
            <p>Flexibility is thus a key feature of the current Japanese stance. Because the current regulations are not based on law, it is a soft approach rather than a hard one. This is the biggest difference between the European and Japanese approaches to technology. One assumption in the European approach is the binary understanding of technology and human rights, in which the former is a threat to the latter. However, the Japanese stance transcends this binary. To those who embrace that binary, the Japanese approach may appear weak. However, if we assume equally positive aspects to technology, the Japanese stance becomes more appropriate. Indeed, the focus on the benefits of AI rather than on its threats is a perspective that allows us to leverage the positive aspects of this technology. Here, AI is not considered a threat but rather a useful instrument for humans. However, its full impact is still unknown and more research is needed on the effectiveness of the Japanese approach to effectively counter the potential risks of AI systems to human rights.</p>
        </sec>
        <sec id="sec12">
            <title>6. LATAM and the search for balance</title>
            <p>This section returns to the situation of LATAM, a region characterized by economic inequalities. The gap between countries in this region and richer countries lies not only in their wealth but also the lagging of development in various sectors, one of them being technology. The objective is then clear. The LATAM region must aim to reduce this development gap, which implies improving important sectors such as technology.</p>
            <p>AI plays a crucial role in this matter. As discussed above, this technology has the potential to promote innovation, which could enable the greater enjoyment of human rights. Hence, the region should avoid a binary logic that places technology and human rights in opposition. Instead, LATAM region should prioritize regulations that stipulate the essential role of technology in improving the condition of human rights. Rather than binaries or negative perspectives that emphasize AI threats to human rights, focus should be put on improving LATAM&#x2019;s technology gap. This approach cannot be made by solely focusing on human rights protections. Rather, it requires placing technology in a key cooperative role for the enjoyment of rights.</p>
            <p>Furthermore, it is crucial to adopt an approach that focuses on LATAM&#x2019;s particularities and unique cultures, rather than one that simply copies foreign frameworks. There is a need for a balanced approach that both considers safeguards for immediate threats to human rights and secures the immediate and long-term benefits of AI for the enjoyment of human rights. In this context, a risk-based policy with a strong emphasis on AI threats to human rights restrains the potential of using AI to promote the enjoyment of human rights. In contrast, a policy choice should transcend protecting human rights to promoting them. This approach would better address LATAM&#x2019;s objective of reducing its technology and development gap. It does not leave rights without protection, but switches the focus from protection only to the widespread promotion of human rights. This implies going beyond harm reduction or avoidance to furthering the promotion of benefits. It is in this logic that a policy about AI should be considered. Strengthening the technology sector in LATAM must be seen as a path for fostering human rights, not the opposite.</p>
            <p>The Japanese approach on this matter thus seems a more advantageous model than the EU AI Act. By relying on previously established regulations to counter AI threats under the competence of science and technology policymaking, this approach can focus on developing a strong technology sector. This paves the way for new technologies that may extend the enjoyment of human rights, ultimately improving human development. The LATAM region could achieve its technology and development objectives by following a similar strategy.</p>
            <p>Measures to protect human rights must be considered in a context that considers the region&#x2019;s objectives. When necessary, if certain AI technologies pose harm to individuals and national security, such technology can be subject to prohibition and special sanctions. However, AI regulations in LATAM should avoid enacting costly compliance measures that may negatively impact innovation. In other words, technology can collaborate with the promotion of human rights. By following a comprehensive strategy like that of Japan and avoiding binarism, the region can strengthen its technology sector. Combined with a strategy for distributing the benefits of AI to all individuals, the LATAM region would leverage the benefits of emerging technologies, shortening its development gap.</p>
        </sec>
        <sec id="sec13" sec-type="conclusion">
            <title>7. Conclusion</title>
            <p>This study has analyzed both the Japanese and EU approaches to AI regulation to propose a model for the LATAM region. The Japanese approach relies on soft law and companies&#x2019; cooperation through the concept of agile governance. The Japanese adopted a deregulatory approach with guidelines and principles, acknowledging the regulations&#x2019; inability to evolve as fast as technology. However, it is important to bear in mind that the Japanese approach is governed solely in the context of science and technology, which facilitates framing AI as a tool for innovation and technological development.</p>
            <p>Conversely, the EU AI Act is not restricted to the technology sector. Perhaps due to this influence, the EU AI Act proposal places more concern on human rights protection, adopting a hard law, risk-based approach, and focusing on the risks AI poses to human rights. The act prohibits specific AI systems as unacceptable risks and stipulates special procedures for high-risk AI, in addition to specific sanctions if the regulation is infringed. In this sense, it could be said that the EU approach emphasizes the negative potential of AI more than the Japanese approach.</p>
            <p>Based on a comparison of both approaches, this study has drawn attention to the dual nature of technological process. AI can be used to both violate human rights and enhance them. With this dual nature in mind and using data from Oxford Insight, the study has also noted the technology gap in the LATAM region. Needs for innovation, science research, and joint venture capital sets LATAM below the global average in technology development. In this regard, this paper argues that overly restrictive regulations will not reduce the technology gap between LATAM and the major global economies.</p>
            <p>On the contrary, the Japanese concept of agile governance stands strongly as a useful approach for LATAM&#x2019;s region needs in technology promotion. This does not imply, however, ignoring the risks AI poses to human rights. Meanwhile, an approach like the EU AI Act should be evaluated bearing in mind the impact of such regulations on the technology sector. High compliance costs can potentially exacerbate the existing weakness in LATAM&#x2019;s technology sector. Consequently, regulations in the region should avoid a binary logic that places excessive focus on AI&#x2019;s risks. In other words, when balancing interests, technology promotion should not be seen as opposed to human rights. Future regulations in LATAM must be mindful that the equitable distribution of the benefits of emerging technologies can enhance human rights.</p>
            <p>There are some limitations to this study. While the EU AI Act remains substantially consistent with its core proposal&#x2014;namely a risk-based approach with a focus on human rights protections&#x2014;this study has focused on the initial proposal, as it was undertaken when the EU AI Act was still in the legislative process. Some minor divergence from the initial proposal and the final act is therefore to be expected.</p>
            <p>Future research should discuss the final act and analyze its various impacts on innovation and technology promotion. That said, only time will reveal the full impact of the EU AI Act on both human rights protection and innovation. Additionally, future research should explore how the Japanese approach deals with AI risks to human rights, which is crucial for analyzing the convenience of laxer regulations.</p>
            <p>Overall, this study stresses the need to consider LATAM-specific requirements regarding AI regulation. It illustrates the need for a comprehensive consideration of AI risks and benefits and context-specific regulation, alongside a need to broaden our view to include Asian perspectives.</p>
            <p>As a result of this study, the following suggestions can be proposed for regulating AI in LATAM. These are meant to serve as a supplement to existing general guidelines and principles from international organizations:
                <list list-type="order">
                    <list-item>
                        <label>1.</label>
                        <p>Latin America should adopt a regulatory approach that promotes innovation and technological advancement similar to the Japanese agile governance model. This model acknowledges the inability of regulations to evolve as quickly as technology and emphasizes cooperation with companies rather than restrictive measures on them.</p>
                    </list-item>
                    <list-item>
                        <label>2.</label>
                        <p>Regulations should balance AI&#x2019;s potential risks to human rights with its benefits, recognizing its dual nature. The focus should not solely be on the risks but also on how AI can enhance human rights.</p>
                    </list-item>
                    <list-item>
                        <label>3.</label>
                        <p>Regulatory frameworks should be tailored to LATAM&#x2019;s specific needs, particularly its technology gap and economic conditions. A restrictive approach could hinder innovation and worsen the existing gap in technological development.</p>
                    </list-item>
                    <list-item>
                        <label>4.</label>
                        <p>Technological development and human rights protections should not be seen as opposing objectives. Future regulations must avoid a binary logic and ensure that the benefits of AI are equitably distributed, assuring both technological growth and human rights protection.</p>
                    </list-item>
                    <list-item>
                        <label>5.</label>
                        <p>Latin American countries should consider not only Western models but also Asian perspectives when developing a holistic, balanced, and future-proof AI regulatory framework.</p>
                    </list-item>
                </list>
            </p>
        </sec>
        <sec id="sec14">
            <title>Ethical considerations</title>
            <p>Ethical approval and consent were not required.</p>
        </sec>
    </body>
    <back>
        <sec id="sec17" sec-type="data-availability">
            <title>Data availability</title>
            <sec id="sec18">
                <title>Third party data</title>
                <p>All data utilized in this study were sourced from publicly available materials, including academic articles accessed via Google Scholar and official documents from government websites. This process includes such keywords as: &#x201c;LATAM AI&#x201d;, &#x201c;Japan AI&#x201d;, and &#x201c;EU AI Act&#x201d;. Selection criteria included relevance to the research question, publication recency, and authoritative sources (government reports, and official policy documents).</p>
                <p>The documents employed in chapters 3 and 4 can be accessed through the website of the Japanese Ministry of Economy, Trade and Industry (METI), and the European Union legislation website (EUR-Lex). The specific sources and corresponding links are detailed in the reference section of the manuscript. These resources are freely accessible, and readers can obtain the same data by visiting the provided links. No additional permissions are required, and no dataset was used in this study.</p>
                <p>Links to the analyzed publications:</p>
                <p>
European Union:
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x25aa;</label>
                            <p>

                                <ext-link ext-link-type="uri" xlink:href="https://www.europarl.europa.eu/doceo/document/TA-8-2017-0051_EN.html">https://www.europarl.europa.eu/doceo/document/TA-8-2017-0051_EN.html</ext-link>
                            </p>
                        </list-item>
                        <list-item>
                            <label>&#x25aa;</label>
                            <p>

                                <ext-link ext-link-type="uri" xlink:href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021PC0206">https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021PC0206</ext-link>
                            </p>
                        </list-item>
                        <list-item>
                            <label>&#x25aa;</label>
                            <p>

                                <ext-link ext-link-type="uri" xlink:href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401689&amp;qid=1725175363474">https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401689&amp;qid=1725175363474</ext-link>
                            </p>
                        </list-item>
                    </list>
                </p>
                <p>Japan:
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x25aa;</label>
                            <p>

                                <ext-link ext-link-type="uri" xlink:href="https://www.meti.go.jp/shingikai/mono_info_service/ai_shakai_jisso/pdf/20210709_8.pdf">https://www.meti.go.jp/shingikai/mono_info_service/ai_shakai_jisso/pdf/20210709_8.pdf</ext-link>
                            </p>
                        </list-item>
                        <list-item>
                            <label>&#x25aa;</label>
                            <p>

                                <ext-link ext-link-type="uri" xlink:href="https://www.meti.go.jp/press/2021/07/20210730005/20210730005-2.pdf">https://www.meti.go.jp/press/2021/07/20210730005/20210730005-2.pdf</ext-link>
                            </p>
                        </list-item>
                        <list-item>
                            <label>&#x25aa;</label>
                            <p>

                                <ext-link ext-link-type="uri" xlink:href="https://www.cas.go.jp/jp/seisaku/jinkouchinou/pdf/humancentricai.pdf">https://www.cas.go.jp/jp/seisaku/jinkouchinou/pdf/humancentricai.pdf</ext-link>
                            </p>
                        </list-item>
                        <list-item>
                            <label>&#x25aa;</label>
                            <p>

                                <ext-link ext-link-type="uri" xlink:href="https://www.meti.go.jp/shingikai/mono_info_service/ai_shakai_jisso/pdf/20220128_2.pdf">https://www.meti.go.jp/shingikai/mono_info_service/ai_shakai_jisso/pdf/20220128_2.pdf</ext-link>
                            </p>
                        </list-item>
                    </list>
                </p>
            </sec>
        </sec>
        <ref-list>
            <title>References</title>
            <ref id="ref2">
                <mixed-citation publication-type="other">
                    <collab>Cabinet Office of Japan</collab>:
                    <article-title>Society 5.0: Co-creating the future.</article-title>
                    <ext-link ext-link-type="uri" xlink:href="https://www8.cao.go.jp/cstp/english/society5_0/">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref1">
                <mixed-citation publication-type="other">
                    <collab>Cabinet Secretariat of Japan</collab>:
                    <article-title>Human-centric AI principles.</article-title>
                    <ext-link ext-link-type="uri" xlink:href="https://www.cas.go.jp/jp/seisaku/jinkouchinou/pdf/humancentricai">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref15">
                <mixed-citation publication-type="other">
                    <collab>Cambridge Yearbook of European Legal Studies</collab>:
                    <article-title>Hard law and soft law regulations of artificial intelligence in investment management.</article-title>
                    <year>2023</year>;<fpage>271</fpage>
                    <ext-link ext-link-type="uri" xlink:href="https://www.cambridge.org/core/journals/cambridge-yearbook-of-european-legal-studies/article/hard-law-and-soft-law-regulations-of-artificial-intelligence-in-investment-management/94A747407D4CA9226C6CCAE3E3E6616E">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref16">
                <mixed-citation publication-type="other">
                    <collab>Center for Strategic and International Studies [CSIS]</collab>:
                    <article-title>Japan&#x2019;s approach to AI regulation and its impact on the 2023 G7 presidency.</article-title>
                    <year>2023</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.csis.org/analysis/japans-approach-ai-regulation-and-its-impact-2023-g7-presidency">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref3">
                <mixed-citation publication-type="other">
                    <collab>Center for Strategic and International Studies (CSIS)</collab>:
                    <article-title>Japan&#x2019;s approach to AI regulation and its impact on the 2023 G7 presidency.</article-title>
                    <year>2023</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.csis.org/analysis/japans-approach-ai-regulation-and-its-impact-2023-g7-presidency">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref4">
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        <fn-group content-type="footnotes">
            <fn id="fn1">
                <label>
                    <sup>1</sup>
                </label>
                <p>Brundage, M., et al., 
                    <italic toggle="yes">The</italic> 
                    <italic toggle="yes">malicious use of artificial intelligence: Forecasting, prevention, and mitigation</italic> (2018), 
                    <ext-link ext-link-type="uri" xlink:href="https://arxiv.org/abs/1802.07228">https://arxiv.org/abs/1802.07228</ext-link>.</p>
            </fn>
            <fn id="fn2">
                <label>
                    <sup>2</sup>
                </label>
                <p>For a comparison of policies in LATAM, see Filgueiras, F. Designing artificial intelligence policy: Comparing design spaces in Latin America (2023). 
                    <ext-link ext-link-type="uri" xlink:href="https://onlinelibrary.wiley.com/doi/abs/10.1111/lamp.12282">https://onlinelibrary.wiley.com/doi/abs/10.1111/lamp.12282</ext-link>
                </p>
            </fn>
            <fn id="fn3">
                <label>
                    <sup>3</sup>
                </label>
                <p>Most of this paper was written during the ongoing discussions about the EU AI Act, and the final text was not yet approved. Hence, much of this paper refers to the proposed text and not the approved version. This article therefore uses the nomenclature &#x201c;EU AI Act&#x201d; to refer to the approved act and &#x201c;EU AI Act proposal&#x201d; to refer to the original proposal.</p>
            </fn>
            <fn id="fn4">
                <label>
                    <sup>4</sup>
                </label>
                <p>

                    <italic toggle="yes">Foro Internacional de la Alianza Latinoamericana para la Inteligencia Artificial</italic> (Foro IALAC, 2023), 
                    <ext-link ext-link-type="uri" xlink:href="https://foroialac.org/vivo/">https://foroialac.org/vivo/</ext-link>.</p>
            </fn>
            <fn id="fn5">
                <label>
                    <sup>5</sup>
                </label>
                <p>

                    <italic toggle="yes">Declaraci&#x00f3;n de Santiago</italic> (Ministerio de Ciencia, Tecnolog&#x00ed;a, Conocimiento e Innovaci&#x00f3;n de Chile, 2023, p. 2), 
                    <ext-link ext-link-type="uri" xlink:href="https://minciencia.gob.cl/uploads/filer_public/40/2a/402a35a0-1222-4dab-b090-5c81bbf34237/declaracion_de_santiago.pdf">https://minciencia.gob.cl/uploads/filer_public/40/2a/402a35a0-1222-4dab-b090-5c81bbf34237/declaracion_de_santiago.pdf</ext-link>.</p>
            </fn>
            <fn id="fn6">
                <label>
                    <sup>6</sup>
                </label>
                <p>

                    <italic toggle="yes">Recomendaciones para una inteligencia artificial fiable</italic> (Gobierno de Argentina, 2023), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.argentina.gob.ar/sites/default/files/2023/06/recomendaciones_para_una_inteligencia_artificial_fiable.pdf">https://www.argentina.gob.ar/sites/default/files/2023/06/recomendaciones_para_una_inteligencia_artificial_fiable.pdf</ext-link>.</p>
            </fn>
            <fn id="fn7">
                <label>
                    <sup>7</sup>
                </label>
                <p>

                    <italic toggle="yes">Segunda Cumbre Ministerial sobre la &#x00c9;tica de la Inteligencia Artificial en Am&#x00e9;rica Latina y El Caribe</italic> (2024), 
                    <ext-link ext-link-type="uri" xlink:href="https://foroialac.org">https://foroialac.org</ext-link>.</p>
            </fn>
            <fn id="fn8">
                <label>
                    <sup>8</sup>
                </label>
                <p>Ley N&#x00b0; 31814-Ley que promueve el uso de la inteligencia artificial en favor del desarrollo econ&#x00f3;mico y social del pa&#x00ed;s (2023), 
                    <ext-link ext-link-type="uri" xlink:href="https://cdn.www.gob.pe/uploads/document/file/5038703/ley-que-promueve-el-uso-de-la-inteligencia-artificial-en-fav-ley-n-31814.pdf?v=1692895308">https://cdn.www.gob.pe/uploads/document/file/5038703/ley-que-promueve-el-uso-de-la-inteligencia-artificial-en-fav-ley-n-31814.pdf?v=1692895308</ext-link>
                </p>
            </fn>
            <fn id="fn9">
                <label>
                    <sup>9</sup>
                </label>
                <p>

                    <italic toggle="yes">Segunda Cumbre Ministerial sobre la &#x00c9;tica de la Inteligencia Artificial en Am&#x00e9;rica Latina y El Caribe</italic> (2024), 
                    <ext-link ext-link-type="uri" xlink:href="https://foroialac.org">https://foroialac.org</ext-link>.</p>
            </fn>
            <fn id="fn10">
                <label>
                    <sup>10</sup>
                </label>
                <p>Oxford Insights. (2023, December). 
                    <italic toggle="yes">Government AI readiness index 2023</italic> (p. 9). 
                    <ext-link ext-link-type="uri" xlink:href="https://oxfordinsights.com/wp-content/uploads/2023/12/2023-Government-AI-Readiness-Index-2.pdf">https://oxfordinsights.com/wp-content/uploads/2023/12/2023-Government-AI-Readiness-Index-2.pdf</ext-link>
                </p>
            </fn>
            <fn id="fn11">
                <label>
                    <sup>11</sup>
                </label>
                <p>Ibid. p. 15.</p>
            </fn>
            <fn id="fn12">
                <label>
                    <sup>12</sup>
                </label>
                <p>Ibid. p. 9.</p>
            </fn>
            <fn id="fn13">
                <label>
                    <sup>13</sup>
                </label>
                <p>United Nations Development Program. (2022). 
                    <italic toggle="yes">Human development report 2021/2022: Uncertain times, unsettled lives: Shaping our future in a transforming world</italic> (ISBN: 9789211264517). United Nations Development Program. 
                    <ext-link ext-link-type="uri" xlink:href="https://hdr.undp.org/system/files/documents/global-report-document/hdr2021-22reportenglish_0.pdf">https://hdr.undp.org/system/files/documents/global-report-document/hdr2021-22reportenglish_0.pdf</ext-link>
                </p>
            </fn>
            <fn id="fn14">
                <label>
                    <sup>14</sup>
                </label>
                <p>

                    <italic toggle="yes">Japan&#x2019;s approach to AI regulation and its impact on the 2023 G7 presidency</italic> (Center for Strategic and International Studies [CSIS], 2023), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.csis.org/analysis/japans-approach-ai-regulation-and-its-impact-2023-g7-presidency">https://www.csis.org/analysis/japans-approach-ai-regulation-and-its-impact-2023-g7-presidency</ext-link>.</p>
            </fn>
            <fn id="fn15">
                <label>
                    <sup>15</sup>
                </label>
                <p>
European Parliament. (2017). 
                    <italic toggle="yes">
European Parliament resolution of 16 February 2017 on civil law rules on robotics</italic> (2015/2103(INL)). 
                    <ext-link ext-link-type="uri" xlink:href="https://www.europarl.europa.eu/doceo/document/TA-8-2017-0051_EN.html">https://www.europarl.europa.eu/doceo/document/TA-8-2017-0051_EN.html</ext-link>
                </p>
            </fn>
            <fn id="fn16">
                <label>
                    <sup>16</sup>
                </label>
                <p>Ibid. Section O.</p>
            </fn>
            <fn id="fn17">
                <label>
                    <sup>17</sup>
                </label>
                <p>Ibid. 
                    <italic toggle="yes">Text of the Introduction, Recitals F, J, and Q</italic> (European Parliament, 2017).</p>
            </fn>
            <fn id="fn18">
                <label>
                    <sup>18</sup>
                </label>
                <p>European Commission. (2021). 
                    <italic toggle="yes">Proposal for a regulation of the European Parliament and of the Council laying down harmonized rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts</italic> (COM/2021/206 final). 
                    <ext-link ext-link-type="uri" xlink:href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021PC0206">https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021PC0206</ext-link>
                </p>
            </fn>
            <fn id="fn19">
                <label>
                    <sup>19</sup>
                </label>
                <p>Initially, the agreement (which was expected by mid-2023) faced several obstacles due to industry leaders&#x2019; concerns about the impact on business and the proposal&#x2019;s slowness to adapt to rapid AI development. Principal disagreement lay in the rules for foundation models following a tiered approach, introducing tighter rules for the most powerful ones that were bound to have more impact on society. For instance, C&#x00e9;dric O, France&#x2019;s former state secretary for digital and a cofounder of the AI startup Mistral, was lobbying for the company, arguing that the AI Act could &#x201c;kill the company.&#x201d; 
                    <italic toggle="yes">EU&#x2019;s AI Act negotiations hit the brakes over foundation models</italic> (Euractiv, 2023), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.euractiv.com/section/artificial-intelligence/news/eus-ai-act-negotiations-hit-the-brakes-over-foundation-models/">https://www.euractiv.com/section/artificial-intelligence/news/eus-ai-act-negotiations-hit-the-brakes-over-foundation-models/</ext-link>.</p>
            </fn>
            <fn id="fn20">
                <label>
                    <sup>20</sup>
                </label>
                <p>
European Commission. Proposal of an Artificial Intelligence Act. Recital 13.</p>
            </fn>
            <fn id="fn21">
                <label>
                    <sup>21</sup>
                </label>
                <p>
European Union. (2024). Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonized rules on artificial intelligence and amending Regulations (EC) N&#x00b0; 300/2008, (EU) N&#x00b0;167/2013, (EU) N&#x00b0; 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act). Official Journal of the European Union. 
                    <ext-link ext-link-type="uri" xlink:href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401689&amp;qid=1725175363474">https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401689&amp;qid=1725175363474</ext-link>
                </p>
            </fn>
            <fn id="fn22">
                <label>
                    <sup>22</sup>
                </label>
                <p>

                    <italic toggle="yes">EU AI Act: First regulation on artificial intelligence</italic> (European Parliament, 2023, June 1), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.europarl.europa.eu/news/en/headlines/society/20230601STO93804/eu-ai-act-first-regulation-on-artificial-intelligence">https://www.europarl.europa.eu/news/en/headlines/society/20230601STO93804/eu-ai-act-first-regulation-on-artificial-intelligence
</ext-link>. The threat level of unacceptable and high risk demands prohibition for the former and registration in an EU database for the latter.</p>
            </fn>
            <fn id="fn23">
                <label>
                    <sup>23</sup>
                </label>
                <p>
European Commission. Proposal of an Artificial Intelligence Act. p. 3.</p>
            </fn>
            <fn id="fn24">
                <label>
                    <sup>24</sup>
                </label>
                <p>Ibid.</p>
            </fn>
            <fn id="fn25">
                <label>
                    <sup>25</sup>
                </label>
                <p>

                    <italic toggle="yes">Hard law and soft law regulations of artificial intelligence in investment management</italic> (Cambridge Yearbook of European Legal Studies, 2023, p. 271), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.cambridge.org/core/journals/cambridge-yearbook-of-european-legal-studies/article/hard-law-and-soft-law-regulations-of-artificial-intelligence-in-investment-management/94A747407D4CA9226C6CCAE3E3E6616E">https://www.cambridge.org/core/journals/cambridge-yearbook-of-european-legal-studies/article/hard-law-and-soft-law-regulations-of-artificial-intelligence-in-investment-management/94A747407D4CA9226C6CCAE3E3E6616E</ext-link>.</p>
            </fn>
            <fn id="fn26">
                <label>
                    <sup>26</sup>
                </label>
                <p>
European Commission. Proposal of an Artificial Intelligence Act. p. 3.</p>
            </fn>
            <fn id="fn27">
                <label>
                    <sup>27</sup>
                </label>
                <p>Ibid., Recital 2.4 - Choice of Instrument.</p>
            </fn>
            <fn id="fn28">
                <label>
                    <sup>28</sup>
                </label>
                <p>Ibid., Explanatory Memorandum, Section 3.5, p. 11.</p>
            </fn>
            <fn id="fn29">
                <label>
                    <sup>29</sup>
                </label>
                <p>Ibid. &amp; European Union. (2024). Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonized rules on artificial intelligence. Recital 138.</p>
            </fn>
            <fn id="fn30">
                <label>
                    <sup>30</sup>
                </label>
                <p>
European Commission. Proposal of an Artificial Intelligence Act. p. 7.</p>
            </fn>
            <fn id="fn31">
                <label>
                    <sup>31</sup>
                </label>
                <p>
European Commission. Proposal of an Artificial Intelligence Act. 9,10.</p>
            </fn>
            <fn id="fn32">
                <label>
                    <sup>32</sup>
                </label>
                <p>For example, see Ebers, M., 
                    <italic toggle="yes">Truly risk-based regulation of artificial intelligence: How to implement the EU&#x2019;s AI Act</italic> (2024), 
                    <ext-link ext-link-type="uri" xlink:href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4870387">https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4870387</ext-link>.</p>
            </fn>
            <fn id="fn33">
                <label>
                    <sup>33</sup>
                </label>
                <p>These objectives are mentioned above, on page 6.</p>
            </fn>
            <fn id="fn34">
                <label>
                    <sup>34</sup>
                </label>
                <p>Habuka notes that the United Kingdom also uses this approach, and places the USA between the UK&#x2019;s approach and the &#x201c;holistic and hard-law-based&#x201d; approach of the EU (Center for Strategic and International Studies [CSIS], 2023), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.csis.org/analysis/japans-approach-ai-regulation-and-its-impact-2023-g7-presidency">https://www.csis.org/analysis/japans-approach-ai-regulation-and-its-impact-2023-g7-presidency</ext-link>.</p>
            </fn>
            <fn id="fn35">
                <label>
                    <sup>35</sup>
                </label>
                <p>

                    <italic toggle="yes">AI Governance in Japan Ver. 1.1</italic> (Ministry of Economy, Trade and Industry [METI], 2021, p. 20), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.meti.go.jp/shingikai/mono_info_service/ai_shakai_jisso/pdf/20210709_8.pdf">https://www.meti.go.jp/shingikai/mono_info_service/ai_shakai_jisso/pdf/20210709_8.pdf</ext-link>.</p>
            </fn>
            <fn id="fn36">
                <label>
                    <sup>36</sup>
                </label>
                <p>Ibid.</p>
            </fn>
            <fn id="fn37">
                <label>
                    <sup>37</sup>
                </label>
                <p>

                    <italic toggle="yes">Governance Innovation Ver. 2</italic> (METI, 2021, p. 2), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.meti.go.jp/press/2021/07/20210730005/20210730005-2.pdf">https://www.meti.go.jp/press/2021/07/20210730005/20210730005-2.pdf</ext-link>.(GOVERNANCE INNOVATION Ver 2).</p>
            </fn>
            <fn id="fn38">
                <label>
                    <sup>38</sup>
                </label>
                <p>

                    <italic toggle="yes">Governance Innovation Ver. 2</italic> (METI, 2021, p. 59), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.meti.go.jp/press/2021/07/20210730005/20210730005-2.pdf">https://www.meti.go.jp/press/2021/07/20210730005/20210730005-2.pdf</ext-link>
                </p>
            </fn>
            <fn id="fn39">
                <label>
                    <sup>39</sup>
                </label>
                <p>Ibid., p. 79.</p>
            </fn>
            <fn id="fn40">
                <label>
                    <sup>40</sup>
                </label>
                <p>Ibid., p. 65</p>
            </fn>
            <fn id="fn41">
                <label>
                    <sup>41</sup>
                </label>
                <p>

                    <ext-link ext-link-type="uri" xlink:href="https://www.meti.go.jp/press/2021/07/20210730005/20210730005-2.pdf">https://www.meti.go.jp/press/2021/07/20210730005/20210730005-2.pdf</ext-link>, p.81-82</p>
            </fn>
            <fn id="fn42">
                <label>
                    <sup>42</sup>
                </label>
                <p>

                    <ext-link ext-link-type="uri" xlink:href="https://www.cas.go.jp/jp/seisaku/jinkouchinou/pdf/humancentricai.pdf">https://www.cas.go.jp/jp/seisaku/jinkouchinou/pdf/humancentricai.pdf</ext-link>, pp.7-11. (HumanCentric AI)</p>
            </fn>
            <fn id="fn43">
                <label>
                    <sup>43</sup>
                </label>
                <p>

                    <ext-link ext-link-type="uri" xlink:href="https://www.meti.go.jp/shingikai/mono_info_service/ai_shakai_jisso/pdf/20220128_2.pdf">https://www.meti.go.jp/shingikai/mono_info_service/ai_shakai_jisso/pdf/20220128_2.pdf</ext-link>, p.17-18. (Governance Guidelines for Implementation of AI Principles)</p>
            </fn>
            <fn id="fn44">
                <label>
                    <sup>44</sup>
                </label>
                <p>

                    <ext-link ext-link-type="uri" xlink:href="https://www.csis.org/analysis/japans-approach-ai-regulation-and-its-impact-2023-g7-presidency">https://www.csis.org/analysis/japans-approach-ai-regulation-and-its-impact-2023-g7-presidency</ext-link>
                </p>
            </fn>
            <fn id="fn45">
                <label>
                    <sup>45</sup>
                </label>
                <p>

                    <ext-link ext-link-type="uri" xlink:href="https://www.sony.com/en/SonyInfo/csr_report/humanrights/AI_Engagement_within_Sony_Group.pdf">https://www.sony.com/en/SonyInfo/csr_report/humanrights/AI_Engagement_within_Sony_Group.pdf</ext-link>
                </p>
            </fn>
            <fn id="fn46">
                <label>
                    <sup>46</sup>
                </label>
                <p>

                    <ext-link ext-link-type="uri" xlink:href="https://www.nec.com/en/press/201904/images/0201-01-01.pdf">https://www.nec.com/en/press/201904/images/0201-01-01.pdf</ext-link>
                </p>
            </fn>
            <fn id="fn47">
                <label>
                    <sup>47</sup>
                </label>
                <p>

                    <ext-link ext-link-type="uri" xlink:href="https://www.fujitsu.com/global/imagesgig5/20190313-01a.pdf">https://www.fujitsu.com/global/imagesgig5/20190313-01a.pdf</ext-link>
                </p>
            </fn>
            <fn id="fn48">
                <label>
                    <sup>48</sup>
                </label>
                <p>

                    <italic toggle="yes">Panasonic and NTT to establish a new joint venture company</italic> (Panasonic, 2022, August 29), 
                    <ext-link ext-link-type="uri" xlink:href="https://news.panasonic.com/global/press/en220829-2">https://news.panasonic.com/global/press/en220829-2</ext-link>
                </p>
            </fn>
            <fn id="fn49">
                <label>
                    <sup>49</sup>
                </label>
                <p>

                    <italic toggle="yes">AI ethical principles</italic> (Epson, n. d.), 
                    <ext-link ext-link-type="uri" xlink:href="https://corporate.epson/en/philosophy/epson-way/principle/ai-ethical-principles.html">https://corporate.epson/en/philosophy/epson-way/principle/ai-ethical-principles.html</ext-link>
                </p>
            </fn>
            <fn id="fn50">
                <label>
                    <sup>50</sup>
                </label>
                <p>In Japan, the Ministry of Justice deals with human rights issues. See Article 2, Items 26-29, Act for Establishment of the Ministry of Justice. In the EU, the European Commission is the primary body responsible for AI-related issues.</p>
            </fn>
            <fn id="fn51">
                <label>
                    <sup>51</sup>
                </label>
                <p>

                    <italic toggle="yes">政策提言</italic> [
                    <italic toggle="yes">Policy Proposal</italic>]. (2023, December 22). Liberal Democratic Party of Japan. 
                    <ext-link ext-link-type="uri" xlink:href="https://www.jimin.jp/news/policy/207268.html">https://www.jimin.jp/news/policy/207268.html</ext-link>
                </p>
            </fn>
            <fn id="fn52">
                <label>
                    <sup>52</sup>
                </label>
                <p>Takaichi, S. (2023, December 22). 会見 [Press conference]. Cabinet Office of Japan. 
                    <ext-link ext-link-type="uri" xlink:href="https://www.cao.go.jp/minister/2309_s_takaichi/kaiken/20231222kaiken.html">https://www.cao.go.jp/minister/2309_s_takaichi/kaiken/20231222kaiken.html</ext-link>
                </p>
            </fn>
            <fn id="fn53">
                <label>
                    <sup>53</sup>
                </label>
                <p>United Nations Development Program. (2022). 
                    <italic toggle="yes">Human development report 2021/2022: Uncertain times, unsettled lives: Shaping our future in a transforming world.</italic> Pg. 160,161. 
                    <ext-link ext-link-type="uri" xlink:href="https://hdr.undp.org/system/files/documents/global-report-document/hdr2021-22reportenglish_0.pdf">https://hdr.undp.org/system/files/documents/global-report-document/hdr2021-22reportenglish_0.pdf</ext-link>
                </p>
            </fn>
            <fn id="fn54">
                <label>
                    <sup>54</sup>
                </label>
                <p>Wang, X., Liu, J., Zhang, Y., &amp; Zhao, W. (2023). Evaluating the impact of industrial pollution on water quality using machine learning techniques. 
                    <italic toggle="yes">Water, Air, &amp; Soil Pollution, 234</italic>(8), Article 694. 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.1007/s11270-023-06694-x">doi:10.1007/s11270-023-06694-x</ext-link>; The Graduate Institute of International and Development Studies. (2023). 
                    <italic toggle="yes">Artificial intelligence and human rights: Final report.</italic> 
                    <ext-link ext-link-type="uri" xlink:href="https://www.graduateinstitute.ch/sites/internet/files/2023-09/AI%26HR%20Final%20Report%20-%20Publication.pdf">https://www.graduateinstitute.ch/sites/internet/files/2023-09/AI%26HR%20Final%20Report%20-%20Publication.pdf</ext-link>
                </p>
            </fn>
            <fn id="fn55">
                <label>
                    <sup>55</sup>
                </label>
                <p>

                    <italic toggle="yes">New technologies for human rights: Law and practice</italic> (Cambridge University Press, 2018), 
                    <ext-link ext-link-type="uri" xlink:href="https://www.cambridge.org/core/books/new-technologies-for-human-rights-law-and-practice/A6473E8A4F6A9ED12675E54A03318802">https://www.cambridge.org/core/books/new-technologies-for-human-rights-law-and-practice/A6473E8A4F6A9ED12675E54A03318802</ext-link>.</p>
            </fn>
            <fn id="fn56">
                <label>
                    <sup>56</sup>
                </label>
                <p>

                    <italic toggle="yes">Prepaid meters are obstacles to accessing water in Africa</italic> (Truthout, 2023), 
                    <ext-link ext-link-type="uri" xlink:href="https://truthout.org/articles/prepaid-meters-are-obstacles-to-accessing-water-in-africa/">https://truthout.org/articles/prepaid-meters-are-obstacles-to-accessing-water-in-africa/</ext-link>.</p>
            </fn>
            <fn id="fn57">
                <label>
                    <sup>57</sup>
                </label>
                <p>Various authors
                    <italic toggle="yes">. Open letter to the representatives of the European Commission, the European Council and the European Parliament.</italic> 
                    <ext-link ext-link-type="uri" xlink:href="https://drive.google.com/file/d/1wrtxfvcD9FwfNfWGDL37Q6Nd8wBKXCkn/view">

                        <italic toggle="yes">https://drive.google.com/file/d/1wrtxfvcD9FwfNfWGDL37Q6Nd8wBKXCkn/view</italic>
</ext-link>
                </p>
            </fn>
            <fn id="fn58">
                <label>
                    <sup>58</sup>
                </label>
                <p>

                    <italic toggle="yes">
European tech companies face an overwhelming amount of rules harming their ability to grow and compete</italic> (EUTech Alliance, 2023), 
                    <ext-link ext-link-type="uri" xlink:href="http://eutechalliance.eu/european-tech-companies-face-an-overwhelming-amount-of-rules-harming-their-ability-to-grow-and-compete/">http://eutechalliance.eu/european-tech-companies-face-an-overwhelming-amount-of-rules-harming-their-ability-to-grow-and-compete/</ext-link>.</p>
            </fn>
        </fn-group>
    </back>
    <sub-article article-type="reviewer-report" id="report373481">
        <front-stub>
            <article-id pub-id-type="doi">10.5256/f1000research.176216.r373481</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Guio-Espa&#x00f1;ol</surname>
                        <given-names>Armando</given-names>
                    </name>
                    <xref ref-type="aff" rid="r373481a1">1</xref>
                    <role>Referee</role>
                </contrib>
                <aff id="r373481a1">
                    <label>1</label>Law School, Harvard University (Ringgold ID: 1812), Cambridge, Massachusetts, USA</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>11</day>
                <month>4</month>
                <year>2025</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Guio-Espa&#x00f1;ol A</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport373481" related-article-type="peer-reviewed-article" xlink:href="10.12688/f1000research.160332.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve-with-reservations</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>The article presents a clear central argument: that Latin American countries should consider adopting an AI regulatory model more closely aligned with Japan&#x2019;s approach rather than the European Union&#x2019;s. The authors argue that the Japanese model is significantly more agile and better suited to addressing both the technological shifts on the horizon and the socio-economic realities of the region.</p>
            <p> </p>
            <p> While the argument contains compelling elements, I believe the text would benefit from the following enhancements: 
                <list list-type="order">
                    <list-item>
                        <p>
                            <bold>Contextual Grounding</bold>: It is advisable to reference existing literature that already compares AI legislation across Latin America and Europe. Additionally, it is worth noting that there are over 100 legislative proposals currently under discussion in the region aimed at regulating AI. Acknowledging this is crucial to understand the broader implications of the authors&#x2019; proposal. See:&#x00a0;https://www.bloomberglinea.com/tecnologia/las-dudas-que-dejan-los-proyectos-de-ley-sobre-inteligencia-artificial-en-latam-en-2025/&#x00a0;</p>
                    </list-item>
                    <list-item>
                        <p>
                            <bold>Moderating the Claim</bold>: The claim that Latin America&#x00a0;
                            <italic>should</italic>&#x00a0;follow the Japanese model over the European one may be too categorical. A more nuanced suggestion might be that the Japanese model offers a valuable and often overlooked alternative regulatory pathway. Due to issues of accessibility and translation, Japanese approaches are not as widely referenced as European ones&#x2014;hence the high probability of the so-called &#x201c;Brussels Effect.&#x201d; The text could more explicitly argue why it is important to diversify sources of regulatory inspiration, including those from Japan.</p>
                    </list-item>
                    <list-item>
                        <p>
                            <bold>Agility and Empirical Support</bold>: The notion of regulatory agility is compelling, but would benefit from further empirical grounding. For instance, the authors might incorporate examples of how hard regulatory frameworks have struggled to adapt to rapid AI developments, especially in relation to more advanced models or use cases.</p>
                    </list-item>
                    <list-item>
                        <p>
                            <bold>Economic Opportunities</bold>: One of the strongest contributions of the piece is its emphasis on the economic growth potential of AI for Latin American countries. To reinforce this, the authors might consider highlighting one or two specific functionalities or applications of AI that illustrate these opportunities.</p>
                    </list-item>
                    <list-item>
                        <p>
                            <bold>Regulatory Experimentation in the Region</bold>: Finally, it is important to recognize the emerging regulatory experimentation agenda across the region, including the development of innovation hubs and regulatory sandboxes. These initiatives may be pivotal in shaping context-sensitive approaches to AI governance and should be incorporated into the analysis.</p>
                    </list-item>
                </list> In sum, the article offers a timely and provocative argument that is highly relevant for the region's scholars and policy makers. I would recommend framing the core message not as a call to abandon the European model, but rather as a call to expand the range of regulatory references. Recognizing the influence of the Brussels Effect, the authors could make a strong case for learning from alternative approaches like Japan&#x2019;s, particularly for their adaptability. I would also suggest including specific recommendations to enable such cross-jurisdictional learning&#x2014;such as mechanisms for regulatory cooperation and knowledge exchange with Japanese experts.</p>
            <p>Is the work clearly and accurately presented and does it cite the current literature?</p>
            <p>Partly</p>
            <p>If applicable, is the statistical analysis and its interpretation appropriate?</p>
            <p>Not applicable</p>
            <p>Are all the source data underlying the results available to ensure full reproducibility?</p>
            <p>No source data required</p>
            <p>Is the study design appropriate and is the work technically sound?</p>
            <p>Yes</p>
            <p>Are the conclusions drawn adequately supported by the results?</p>
            <p>Yes</p>
            <p>Are sufficient details of methods and analysis provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Reviewer Expertise:</p>
            <p>My research focuses on the governance of emerging technologies, particularly artificial intelligence. I&#x2019;m especially interested in how regulatory innovation&#x2014;such as sandboxes and experimental frameworks&#x2014;can support responsible AI development. I work on the design of national AI strategies and institutional models in the Global South, with a strong emphasis on inclusive policymaking, global cooperation, and aligning technology with social needs.</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.</p>
        </body>
    </sub-article>
    <sub-article article-type="reviewer-report" id="report373488">
        <front-stub>
            <article-id pub-id-type="doi">10.5256/f1000research.176216.r373488</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Vidaki</surname>
                        <given-names>Anastasia Nefeli</given-names>
                    </name>
                    <xref ref-type="aff" rid="r373488a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-9371-3370</uri>
                </contrib>
                <aff id="r373488a1">
                    <label>1</label>Vrije Universiteit Brussel, Brussels, Brussels, Belgium</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>4</day>
                <month>4</month>
                <year>2025</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Vidaki AN</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport373488" related-article-type="peer-reviewed-article" xlink:href="10.12688/f1000research.160332.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve-with-reservations</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>In the paper under review, the researchers investigate the appropriate policy-making and legislative approaches to AI in LATAM countries. In order to do so they proceed to an exploration of the AI regulatory choices employed both by the European Union (EU AI Act) and by Japan (agile governance scheme).</p>
            <p> </p>
            <p> They start by briefly describing the financial and technological landscape in the LATAM region and mentioning the national and transnational initiatives in place to regulate AI development. This analysis allows them to showcase the regulatory gaps that affect the economy and technological innovation and widen the chasm between the LATAM and high-income countries.</p>
            <p> </p>
            <p> They move forward to an overview of the EU AI governance model, which entails an HR-centered, hard-law regulatory option, namely the EU AI Act. The authors delve into its risk-based approach by going through its main provisions. However, they rely on the initial proposal of the Act, not the approved, final draft of the legislation.</p>
            <p> </p>
            <p> In the next section, they discuss the soft-law, agile governance model that Japan has opted for the AI regulation, which encourages both the governmental and the private sector to produce and adhere to AI development and usage guidelines and best practices. In Japan, it appears that the debates surrounding AI regulation are still on an initial level.</p>
            <p> </p>
            <p> After the examination of those regulatory models, they juxtapose them in order to spot their benefits and weaknesses. Regarding the EU one, they observe that although it aims to safeguard human rights, it jeopardises technological innovation, posing obstacles to AI developers and relevant enterprises who aspire to integrate, operate within, or target the EU market. According to the authors, in the EU sphere, there seems to be a focus on the negative aspects of AI which outweigh their positive ones. On the contrary, while the Japanese option allows for flexibility and enhances technological development, it cannot ensure compliance of the private entities.</p>
            <p> </p>
            <p> Coming back to LATAM countries, they suggest that the Japanese model is more appropriate as a policy option, since it allows technological advancement, which is important for the region&#x2019;s economic growth and competitiveness. At the same time, it is expected to promote the protection of human rights. In the end, they propose five principles, towards which the AI regulation in LATAM countries should be targeted.</p>
            <p> </p>
            <p> The paper discusses an innovative and interesting policy perspective to AI regulation, which is currently missing from the academic research. By adopting a comparative method, the authors present two regulatory models, the hard-law, human-rights-based and rigid EU and the soft-law, agile-governance-based and flexible Japanese one, with their particularities.</p>
            <p> </p>
            <p> However, some points deserve the researchers&#x2019; attention and might require further additions or refinement; 
                <list list-type="bullet">
                    <list-item>
                        <p>The core of the paper, namely, the comparison between the EU and the Japanese approach to AI regulation and the examination of their applicability for the regulation of AI in the LATAM region is overlooked in the given
                            <bold> title</bold>.</p>
                    </list-item>
                    <list-item>
                        <p>The authors should add an
                            <bold> explanation of why they chose to focus on the EU and Japanese models instead of examining others</bold>, such as the US one.</p>
                    </list-item>
                    <list-item>
                        <p>In the second section, there is an analysis on the AI development status in LATAM countries, which sheds light on the underdeveloped technological and financial sector and some policy initiatives already in place on national and transnational levels. This is also connected to the pre-final paragraph, where the LATAM policy recommendations are discussed. It would be beneficial for the researchers to bear in mind and to briefly outline the 
                            <bold>political particularities</bold> that differentiate LATAM countries from the, as mentioned in the paper, high-income ones.</p>
                    </list-item>
                    <list-item>
                        <p>Regarding the EU approach, there is a focus on the EU AI Act, while
                            <bold> other legislative tools</bold> at hand have not even been highlighted. For the support of the expressed arguments, the authors could check the Proposal for a Directive on adapting noncontractual civil liability rules to artificial intelligence and add if they consider it necessary.</p>
                    </list-item>
                    <list-item>
                        <p>In the final paragraph of the section presenting and evaluating the Japanese approach, it is suggested to elaborate more on the issues that might come with the unwillingness of private corporations to align with the AI principles suggested by the Cabinet Office. Indeed, what are the 
                            <bold>drawbacks of the Japanese model</bold>?
                            <bold> How should they be tackled</bold> if we want to apply it to the LATAM region? The latter can be discussed also in the section on &#x2018;LATAM and the search for balance&#x2019;.</p>
                    </list-item>
                    <list-item>
                        <p>There is a 
                            <bold>lack of references</bold> in the section entitled &#x2018;LATAM and the search for balance&#x2019;. It is understandable that in that one the writers develop their thoughts and recommendations, but it would be advisable to add some.</p>
                    </list-item>
                    <list-item>
                        <p>Some 
                            <bold>word repetitions </bold>can be spotted in parts of the text (emphasize, recognize the need, etc). Please try to rephrase.</p>
                    </list-item>
                </list> Overall, if these points are addressed and clarified, the clear articulation of the arguments in the paper, its comprehensive structure and language along with its unique perspective advocate for its indexing.</p>
            <p> </p>
            <p> https://commission.europa.eu/business-economy-euro/doing-business-eu/contract-rules/digital-contracts/liability-rules-artificial-intelligence_en</p>
            <p>Is the work clearly and accurately presented and does it cite the current literature?</p>
            <p>Yes</p>
            <p>If applicable, is the statistical analysis and its interpretation appropriate?</p>
            <p>Not applicable</p>
            <p>Are all the source data underlying the results available to ensure full reproducibility?</p>
            <p>Yes</p>
            <p>Is the study design appropriate and is the work technically sound?</p>
            <p>Yes</p>
            <p>Are the conclusions drawn adequately supported by the results?</p>
            <p>Yes</p>
            <p>Are sufficient details of methods and analysis provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Reviewer Expertise:</p>
            <p>AI ethics, AI policy, EU ICT law, EU AI law, sociology of law and emerging technologies</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.</p>
        </body>
        <sub-article article-type="response" id="comment13853-373488">
            <front-stub>
                <contrib-group>
                    <contrib contrib-type="author">
                        <name>
                            <surname>Akiyama</surname>
                            <given-names>Hajime</given-names>
                        </name>
                        <aff>University of Tsukuba, Japan</aff>
                    </contrib>
                </contrib-group>
                <author-notes>
                    <fn fn-type="conflict">
                        <p>
                            <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                    </fn>
                </author-notes>
                <pub-date pub-type="epub">
                    <day>7</day>
                    <month>5</month>
                    <year>2025</year>
                </pub-date>
            </front-stub>
            <body>
                <p>The authors would like to express their gratitude to the reviewer. Her detailed review of our paper has allowed us to identify areas where more precision is beneficial. Moreover, her commendation of the innovative perspective of our paper has encouraged the authors to further elaborate on our arguments. The authors have thoughtfully considered the review and decided to include the suggestions, as outlined below: 
                    <list list-type="bullet">
                        <list-item>
                            <p>Point No. 1 on improving the paper&#x2019;s title&#x00a0;</p>
                        </list-item>
                    </list> The authors appreciate this crucial remark. They will amend the article&#x2019;s title to better reflect its core focus.</p>
                <p> &#x00a0; 
                    <list list-type="bullet">
                        <list-item>
                            <p>Point No. 2 on the explanation of why the focus on Japanese and EU models instead of others&#x00a0;</p>
                        </list-item>
                    </list> The reviewer&#x2019;s suggestion will enhance the explanation of our methodology and support the future replication of our research. They will include an explanation on the selected models into the section about methods.</p>
                <p> &#x00a0; 
                    <list list-type="bullet">
                        <list-item>
                            <p>Point No. 3 on briefly outlining the political particularities that differentiate LATAM countries</p>
                        </list-item>
                    </list> To further discuss the context of LATAM countries, the authors will reference the political particularities of LATAM countries in comparison to high-income ones in the section &#x201c;2. AI in LATAM&#x201d;.&#x00a0;</p>
                <p> &#x00a0; 
                    <list list-type="bullet">
                        <list-item>
                            <p>Point No. 4 on further considering such EU policies as the Proposal for a Directive on adapting noncontractual civil liability rules to AI</p>
                        </list-item>
                    </list> While the scope of our article focuses on the EU AI Act, the authors agree with the reviewer that referencing other EU AI policies will strengthen our arguments. They will include the proposed Directive when explaining the EU approach in section &#x201c;3. The EU approach&#x201d;.</p>
                <p> &#x00a0; 
                    <list list-type="bullet">
                        <list-item>
                            <p>Point No. 5 on the drawbacks of the Japanese model and how to tackle them</p>
                        </list-item>
                    </list> In the paper, the authors outline some issues with the Japanese model and the necessary guardrails, particularly regarding corporate commitment. While proposing solutions to these drawbacks is not the focus of the authors&#x2019; paper, they will emphasize these disadvantages and present some alternatives to address these issues in section &#x201c;4. The Japanese approach&#x201d;.</p>
                <p> &#x00a0; 
                    <list list-type="bullet">
                        <list-item>
                            <p>Point No. 6 on the lack of references in the section entitled &#x2018;LATAM and the search for balance&#x2019;</p>
                        </list-item>
                    </list> As the reviewer kindly points out, the authors elaborated on their main arguments. However, they will follow the advice and add more references.</p>
                <p> &#x00a0; 
                    <list list-type="bullet">
                        <list-item>
                            <p>Point No. 7 on word repetitions</p>
                        </list-item>
                    </list> The authors will reduce word repetitions.</p>
                <p> </p>
                <p> Enzo Dunayevich and Hajime Akiyama</p>
            </body>
        </sub-article>
    </sub-article>
</article>
