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  <front>
    <journal-meta>
      <journal-title-group>
        <journal-title>Regulatory sandboxes draw from the concept of sandbox in computer science. This “technical” sandbox can be defined
as “a restricted, controlled execution environment that prevents potentially malicious software, such as mobile code, from
accessing any system resources except those for which the software is authorized” (as retrieved from the NIST Glossary,
source NIST SP</journal-title>
      </journal-title-group>
    </journal-meta>
    <article-meta>
      <title-group>
        <article-title>A working experimentation model for cyber resilience regulatory sandboxes</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Fabio Seferi</string-name>
          <email>fabio.seferi@imtlucca.it</email>
          <xref ref-type="aff" rid="aff0">0</xref>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Joint National Conference on Cybersecurity, ITASEC &amp; SERICS 2025</institution>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>University of Florence, Department of Legal Sciences</institution>
          ,
          <addr-line>Via delle Pandette 32, 50127, Florence</addr-line>
          ,
          <country country="IT">Italy</country>
        </aff>
      </contrib-group>
      <pub-date>
        <year>1800</year>
      </pub-date>
      <volume>180</volume>
      <fpage>0</fpage>
      <lpage>21</lpage>
      <abstract>
        <p>In today's volatile and highly dynamic global environment, regulators and stakeholders encounter significant challenges in addressing cyber risk, particularly considering rapidly evolving digital technologies and of the lack of instruments to anticipate specific scenarios in controlled environments. This paper first examines the potential of cyber risk mitigation through regulatory experimentation, in the context of regulatory sandboxes. Through the analysis of 43 relevant use cases, the research focuses on the evaluation of the role of risk management measures within regulatory sandboxes. Against this backdrop, the article then proposes a working experimentation model for cyber resilience - titled the “3PS model” and comprising Products, Systems, Processes and Services as components, which could be used for Procedural or Security functions. This working experimentation model could serve as a foundation for future real-world applications (e.g., in the field of cyber resilience regulatory sandboxes).</p>
      </abstract>
      <kwd-group>
        <kwd>eol&gt;regulatory sandboxes</kwd>
        <kwd>cybersecurity</kwd>
        <kwd>cyber resilience</kwd>
        <kwd>Cyber Resilience Act</kwd>
        <kwd>regulatory experimentation1</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>1. Introduction</title>
      <p>Novel digital technologies are transforming the landscape of our society at an unprecedented pace,
offering great opportunities for innovation and social advancement. Acceleration is a core feature of
diagnoses for contemporary social development [1]. This rapid evolution can outpace the ability of
citizens and regulators to understand and mitigate associated risks, leading to societal impacts that
are difficult to predict or control. Social control of technology has indeed been a core issue of
scientific literature in the past decades, posing the central question of decision makers navigating in
the uncharted waters of regulation [2].</p>
      <p>Regulatory sandboxes have seen an increasing interest in European Union (EU) and national
regulatory efforts as a measure both to govern and regulate new technologies in a timely manner,
whilst also supporting innovation. They can be considered as a form of “structured experimentalism”
[3], allowing for experimentation in a protected environment through the application of appropriate
guardrails to insulate the wider context from possible negative externalities of such experimentation.</p>
      <p>In brief, regulatory sandboxes can be described as “schemes that enable firms to test innovations
in a controlled real-world environment, under a specific plan developed and monitored by a
competent authority” [4].2 They could also include testing in real-world conditions and with real
customers. These flexible schemes have also caught the attention of the EU legislator, who in 2024
adopted three different Regulations that foresee the establishment of regulatory sandboxes in the
digital domain: the Interoperable Europe Act (Regulation (EU) 2024/903), the Artificial Intelligence
Act (Regulation (EU) 2024/1689), and the Cyber Resilience Act (Regulation (EU) 2024/2847).</p>
      <p>However, there remains a notable gap for a conceptual framework on how experimentation
within regulatory sandboxes can effectively support the adoption and testing of cybersecurity
requirements. A shared understanding and standardised approach to experimentation is fundamental
to ensuring consistent and comparable outcomes across different types of regulatory sandboxes. Such
uniformity would strengthen their collective capacity to enhance the cyber resilience of entities and
to have in turn better-informed cyber policy formulation. In this view, this paper proposes an
experimentation model designed to serve as a starting basis for implementing so-called “cyber
resilience regulatory sandboxes”. To do so, the paper is structured as follows: Section 2 illustrates the
concept of regulatory sandboxes between normative frameworks and relevant literature. Section 3
highlights the role of risk management measures within regulatory sandboxes and identifies some
core components to be taken into consideration for their related experimentation. On this basis,
Section 4 outlines a working model for experimentation on cyber resilience. Lastly, Section 5 presents
the main conclusions derived from the research and some considerations that outline possible future
work on the topic.</p>
    </sec>
    <sec id="sec-2">
      <title>2. Framing regulatory sandboxes</title>
      <p>2.1.</p>
      <sec id="sec-2-1">
        <title>Relevant normative frameworks at EU level</title>
        <p>Regulatory sandboxes have emerged as important regulatory and policy mechanisms for
experimentation and adaptive regulation, especially at EU level. They form one of the tools for better
regulation, as envisaged in the 2023 “Better regulation Toolbox” of the European Commission:
regulatory sandboxes are listed as one of the approaches under Tool #69 on emerging methods and
policy instruments [4]. EU’s Better Regulation agenda aims to ensure evidence-based and transparent
law-making, also based on the views of the impacted stakeholders. In this context, regulatory
sandboxes provide for evidence-based regulation of innovation, while also considering the specific
hurdles of participating actors.</p>
        <p>To this regard, the Council of the European Union adopted a document of Conclusions on
regulatory sandboxes and experimentation clauses in 2020 [5]. These conclusions highlighted the use
of regulatory sandboxes in the context of digitalisation, and stressed how this policy instrument can:
(a) provide the opportunity for advancing regulation through proactive regulatory learning, thus
based on real-world evidence, in contexts of high uncertainty and disruptive challenges; and (b) offer
significant possibilities for innovation and growth for businesses (in particular, for SMEs,
microenterprises as well as start-ups), industry, and public services.</p>
        <p>Between legal definitions and real-world examples, regulatory sandboxes generally share several
core features [6]. They involve a structured approach to development and testing of innovative
technologies before market deployment, in view of the general objective of attaining regulatory
learning. Innovations are developed and tested in a controlled environment, which could include
(near) real-world conditions. Participation in regulatory sandboxes is governed through a specific
plan developed with, and monitored by, a competent authority (the one setting up and running the
regulatory sandbox). The operation of regulatory sandboxes with respect to the admitted projects is
usually organized on a case-by-case basis: this may involve a temporary loosening of applicable rules
(through derogations, waivers or exemptions), while also maintaining specific safeguards to preserve
the overall regulatory objectives [6].</p>
        <p>
          For digital solutions, three EU Regulations that entered into force in 2024 envisage the
establishment of regulatory sandboxes: the Interoperable Europe Act (IEA), the Artificial Intelligence
Act (AIA), and the Cyber Resilience Act (CRA). The Interoperable Europe Act (Regulation (EU)
2024/903) focuses on the promotion of cross-border interoperability of trans-European digital public
services, thus applying to entities and public sector bodies that either regulate, provide, manage or
implement such services [cf. Article 1(
          <xref ref-type="bibr" rid="ref1 ref2">1-2</xref>
          ) IEA]. This Regulation foresees the possibility of
establishing so-called “interoperability regulatory sandboxes” as a support measure for the overall
objectives of an Interoperable Europe [cf. Articles 11 and 12 IEA]. Interoperability regulatory
sandboxes refer to controlled environments for the development, training, testing and validation of
innovative interoperability solutions, where appropriate in real world conditions [cf. Article 2(
          <xref ref-type="bibr" rid="ref14">14</xref>
          )
IEA]. For a comprehensive analysis of interoperability regulatory sandboxes, refer to [7].
        </p>
        <p>
          On the other hand, the Artificial Intelligence Act (Regulation (EU) 2024/1689) has the purpose to
promote the uptake of human-centric and trustworthy AI, while ensuring a high level of protection
of health, safety, and fundamental rights against the harmful effects that AI systems may have in the
EU. It is the only Regulation from the referred ones at EU level that foresees the mandatory
establishment of national “AI regulatory sandboxes”, which shall be operational by 2 August 2026 [cf.
Article 57(
          <xref ref-type="bibr" rid="ref1">1</xref>
          ) AIA]. This type of regulatory sandboxes provides for a controlled framework to develop,
train, validate and test – including in real-world conditions – innovative AI systems before market
launch, fostering innovation and ensuring regulatory compliance [cf. Article 3(55) AIA]. For more
details on AI regulatory sandboxes under the AI Act refer to [8] and [9].
        </p>
        <p>
          However, the interplay between cybersecurity requirements and regulatory sandboxes finds a
practical application in the Cyber Resilience Act (Regulation (EU) 2024/2847). This Regulation
provides rules for deploying products with digital elements while ensuring their overall
cybersecurity. In this view, it foresees several essential requirements for the design, development and
production of such products and for the vulnerability handling processes put in place by
manufacturers [cf. Article 1 CRA]. The Regulation lays down the possibility for Member States to
establish “cyber resilience regulatory sandboxes”, thus providing for controlled testing environments
for innovative products with digital elements to facilitate their development, design, validation and
testing for the purpose of complying with the provisions envisioned in the Regulation itself [cf.
Article 33(
          <xref ref-type="bibr" rid="ref2">2</xref>
          ) CRA]. For the many interactions between the Cyber Resilience Act and the Artificial
Intelligence Act with respect to regulatory sandboxes, refer to [10] and [11].
        </p>
        <p>There are not many elements yet on how future cyber resilience regulatory sandboxes should and
will look like in terms of design, functioning, outcome and effectiveness. Their establishment is
driven by the testing of the essential cybersecurity requirements. This paper conceptualizes a
possible framework for any type of regulatory sandbox starting from the components of
experimentation, leaving the possibility to regulators and participating entities to define the most
appropriate cybersecurity requirements and modalities of implementation.
2.2.</p>
      </sec>
      <sec id="sec-2-2">
        <title>State of the art</title>
        <p>The many facets of regulatory sandboxes have been the focus of a recent collective work [11], to
which is referred for further insights and detailed analyses. Regulatory sandboxes have also been at
the centre of several specialised studies and reports, including from the European Commission [6],
the OECD [12], the European Parliament [14], the Joint Research Centre [15] and the European
Supervisory Authorities [16]. The present Subsection, however, briefly highlights some key
considerations from scientific literature that are relevant for the continuation of the analysis.</p>
        <p>Regulatory sandboxes allow for a crucial environment where to pursue responsible innovation,
due to the specific conditions of engagement between stakeholders (regulators and innovators), and
to it being an iterative and collaborative process. In principle, in anticipating risks and functioning of
innovative solutions that do not currently fit the legal framework, regulators can buttress its
development in respect of core societal values, principles and ethical considerations. Their theoretical
role of promoting secure and responsible innovations is widely shared across the community of
policymakers, regulators, entrepreneurs and researchers [17]. Moreover, the (social) interaction
between regulators and regulated entities within sandboxes may increase the latter’s risk
management capabilities [18]. Indeed, by involving those affected by regulation in the
experimentation activity, these spaces enhance legitimacy and trust in both innovative solutions and
regulatory practices [19].</p>
        <p>One of the main open problems in the research area is that, from a practical perspective, there has
not been a common understanding of what a regulatory sandbox should be and what it should entail.
Focusing on one feature or the other often leads regulators and policymakers to either frame a
regulatory experiment as a sandbox or disregard it. Indeed, research has shown that the
understanding of regulatory sandboxes and experimentation varies significantly also across
participating (or interested) entities [20]. This is translated into another key concern: the results of
experimentation may not be easily scalable or replicable, as they are often tailored to specific contexts
[19]. Moreover, the application of regulations stemming from different sectors to the same product
complicates the experimentation process given the need to have a coordinated governance and
interplay of multiple different authorities at the same time [21]. Another related problem refers to the
practical implementation of this instrument [21]. For example, the effectiveness of regulatory
learning within and as an outcome of regulatory sandboxes remains to be seen. In this view, a
comprehensive conceptualisation of how this regulatory learning process could work into practice is
still lacking, in particular with respect to the testing and implementation of cybersecurity
requirements. Coupled to this, regulators and public administration bodies often lack the necessary
resources (and even competences) to effectively run these schemes [19].</p>
        <p>Ultimately, regulatory experimentation – exemplified in this paper with regulatory sandboxes as
one of its main recent applications – implies the testing, piloting or trial of a new product, service,
approach or process, in such a way as to generate and gather evidence that can inform the design or
administration of a regulatory regime. This is particularly relevant also for cybersecurity law and
regulation.</p>
      </sec>
    </sec>
    <sec id="sec-3">
      <title>3. The role of risk management</title>
      <p>3.1.</p>
      <sec id="sec-3-1">
        <title>Regulatory sandboxes as risk management instruments</title>
        <p>Regulatory sandboxes, as illustrated, serve as mechanisms for experimenting with innovative
solutions under regulatory supervision and before market deployment. A central role is played by the
development and testing of products. In this context, cybersecurity requirements guarantee that
innovative products are made available in the market without any known vulnerabilities; coupled
with this, regulatory sandboxes may enhance the overall risk management posture of the
participating entities.</p>
        <p>Indeed, many regulatory sandboxes foresee the adoption of specific measures in terms of risk
management, which are often envisaged as selection criteria for accessing the sandbox environment:
thus, risk management becomes one of the dimensions on which basis the projects are evaluated for
admission and for the experimentation to start. This is in line with adopting appropriate safeguards
that contribute to having a protected and controlled experimentation. Building on previous work
[22], risk management measures have been identified and analysed in 43 relevant use cases of
regulatory sandboxes and experimentation initiatives, ranging from financial services to energy,
transportation and emerging technologies (see Table 2 in Appendix for the list of uses cases and
related risk management measures envisaged).3</p>
        <p>These measures cover multiple dimensions of risk management. First, a focus on the specific
solution is placed in many cases, including the interaction between the product and its end users (i.e.,
consumers). For example, in the case of “Australia - AEMC's Energy Regulatory Sandboxes” [UC40],
adequate consumer protections are required in connection with the trial project. For the “Bahrain
CBB's Financial Services Regulatory Sandbox” case [UC02], it is necessary to adopt cybersecurity and
other relevant measures to ensure safety of the innovative solution (or service) – thus, it also places a
strong emphasis on cybersecurity measures. In addition, in the cases of “India - RBI's Financial
Services Regulatory Sandbox” [UC07] and “Philippines - BSP's Financial Services Regulatory
Sandbox” [UC17], two specific aspects emerge: (i) the adoption of adequate built-in safeguards for IT
3 The financial services sector represents the largest group, with 31 occurrences. This prevalence is not unexpected, as
regulatory sandboxes have become a prominent practice within this industry. On the other hand, a total of 8 use cases
pertains to cross-sectoral schemes, although they may be focused on specific technologies (such as “Spain - AI Regulatory
Sandbox Pilot Scheme” [UC30]). Finally, energy and transportation are represented by 2 use cases each. Please refer to Table
2 in the Appendix for more details.
systems, and (ii) the assessment and mitigation of significant risks. This highlights how (cyber) risk
management is not only viewed in relation to the specific solution undergoing experimentation, but
also as a general requirement for the IT architecture of the participating entity.</p>
        <p>Some of the risk assessments required across regulatory sandboxes are also tailored to the specific
type of product considered for experimentation and to its characteristics. In this view, AI systems in
the case of “Spain - AI Regulatory Sandbox Pilot Scheme” [UC37] undergo evaluations for their
societal impact and for their likelihood of becoming high-risk AI systems (which specific
requirements apply to under the Artificial Intelligence Act). This is the case also for “Austria
Framework Conditions for Automated Driving” [UC42], in which it is required the performance of a
specific route analysis and risk assessment for the planned test route area: the results of this activity
then feed into the risk management process for the test plan, thus incorporating precise feedback
loops.</p>
        <p>Risk management is also required throughout the innovation lifecycle, involving continuous risk
monitoring and mitigation processes. In the case of “Portugal - Free Zones for Technology” [UC35] it
is required to define a monitoring plan for carrying out the testing, and clear risk assessment and
mitigation strategies. The latter also applies to the use cases “Saudi Arabia - CST's Emerging
Technologies Regulatory Sandbox” [UC36] and “Saudi Arabia - SAMA's Open Banking Regulatory
Sandbox” [UC19], or to “Brazil - BCB's Financial Services Regulatory Sandbox” [UC03]. In the
“Singapore - MAS's FinTech Regulatory Sandbox” case [UC20], the definition of boundaries to limit
the scale of testing and associated risks is also required. In the case of “Oman - CBO's Fintech
Regulatory Sandbox Framework” [UC16], an emergency exit strategy is also required for the
situations in which live testing either fails or is discontinued. Another aspect is tied to elements such
as business continuity and disaster recovery plans, as in the case of “Bahrain - CBB's Financial
Services Regulatory Sandbox” [UC02]. Regulatory sandboxes may require the specification of the
methods in place to address possible consumer complaints emerging during experimentation (e.g.,
“United States - Florida's Financial Technology Sandbox Innovator” [UC25]). In the case of “United
Arab Emirates - ADGM's FinTech RegLab” [UC24], projects may also be selected to their potential of
promoting better risk management solutions for the financial industry. Hence, risk management is
not only a requirement but becomes also a clear objective of the overall regulatory sandbox scheme.</p>
        <p>
          As this analysis has shown (see all relevant measures listed in Table 2 in Appendix), regulatory
sandboxes play an important role for requiring and pursuing adequate levels of risk management
throughout participation and experimentation. This would most likely be reflected also in the
regulatory sandboxes to be established under the EU Regulations recalled before. Indeed, for
interoperability regulatory sandboxes, a risk management and monitoring mechanism is required as
part of the participation plan [cf. Article 12(
          <xref ref-type="bibr" rid="ref3">3</xref>
          ) point d) IEA]. For AI regulatory sandboxes, risk
management [cf. Article 9 AIA] and cybersecurity [cf. Article 15 AIA] are among the measures that
could be tested for high-risk AI systems. For the Cyber Resilience Act, a specific evaluation of the
applicable essential cybersecurity requirements is made in Subsection 4.2.
3.2.
        </p>
      </sec>
      <sec id="sec-3-2">
        <title>Main components for risk management in experimentation</title>
        <p>There is however a gap in literature when it comes to analysing how cybersecurity requirements are
evaluated and adopted in practice within regulatory sandboxes – and how this can be done in future
iterations of such schemes. This becomes even more relevant if we consider the possible
establishment of cyber resilience regulatory sandboxes as envisaged by the CRA, which should focus
on the essential requirements defined therein.</p>
        <p>As the analysis above has shown, regulatory sandboxes could be utilized for a broader
conceptualisation of risk management. In particular, with respect to cyber risk, the application and
testing of requirements may extend beyond products alone, as the very concept of cyber resilience
encompasses more than just product safety. Cyber resilience indeed refers to “[t]he ability to
anticipate, withstand, recover from, and adapt to adverse conditions, stresses, attacks, or
compromises on systems that use or are enabled by cyber resources; [it] is intended to enable mission
or business objectives that depend on cyber resources to be achieved in a contested cyber
environment”.4</p>
        <p>
          The examination of the measures foreseen as selection criteria in the 43 use cases analysed can be
useful in identifying the core components of experimentation. These components should enable a
better framing of the scope of experimentation, allowing for cross-regulation testing. By making the
experimentation driven by common components, regulatory sandboxes may provide a safe space to
apply and test requirements deriving from different regulations simultaneously. This possibility is
clearly envisaged in interoperability and AI regulatory sandboxes: both acts foresee guidance,
supervision and support in relation to the requirements of the regulations pertaining to the
regulatory sandbox’s scope, but also, where relevant and appropriate, for other EU and national law
[cf. Article 11(
          <xref ref-type="bibr" rid="ref2">2</xref>
          )(g) IEA and Article 57(
          <xref ref-type="bibr" rid="ref6">6</xref>
          ) AIA].
        </p>
        <p>The proposed core components for experimentation are products, systems, processes and
services. A product is a “part of the equipment (hardware, software and materials)”5. This component
entails experimenting with requirements for the design, development, and testing of products. It
implies the application of a modular risk framework that could then allow tailoring assessments
based on product type. A focus on products, particularly those with digital elements that fall within
the scope of the CRA, ensures they meet cybersecurity requirements and are aligned with evolving
compliance and procurement standards. For example, such component can be found in the
“Singapore - MAS's FinTech Regulatory Sandbox” case [UC20] (framed as assessment and mitigation
of significant risks arising from the proposed solution), in “United States - West Virginia's FinTech
Sandbox” [UC30] (as identification of possible risks to consumers in relation to the innovative
product), in “United Arab Emirates - RegLab” [UC38] (as identification of risks associated with testing
or implementing the proposed solution), or in “Austria - Framework Conditions for Automated
Driving” [UC42] (as identification and prevention of further risks through a risk analysis for the
entire test project).</p>
        <p>A system may be defined as a “discrete set of resources organized for the collection, processing,
maintenance, use, sharing, dissemination, or disposition of information”6. This component entails the
testing of specific systems, networks and infrastructure. Testing of critical systems, especially those
operating in high-risk environments, contributes to developing standardized protocols for broader
implementation. This is the case for “India - RBI's Financial Services Regulatory Sandbox” [UC07],
which foresees the adoption of adequate built-in safeguards for IT systems to enable their proper
protection. In this case, systems are enablers of secure experimentation, thus being ontologically
different from single products. The system component may be derived also from the “South Korea
FSC's Financial Services Regulatory Sandbox” case [UC21], in particular for the assessment of the
potential systemic risks posed by the proposed solution or service, coupled with the evaluation of the
project’s impact on the integrity of the financial market. This poses also the question of
interconnectedness between different resources – key for market stability – expanding the scope
beyond products.</p>
        <p>A process is a “set of interrelated or interacting activities that use inputs to deliver an intended
result”7. This component focuses on the experimentation of specific scenarios for the stress-test of
defined processes. Testing a process helps regulators identify potential vulnerabilities, enabling the
updating of relevant practices and standards. For example, in the case of “Italy - Financial Services
Regulatory Sandbox” [UC09], this component is connected to the improvement of risk management
systems, procedures and processes for operators, or to the increased effectiveness in identifying
and/or measuring and managing risks. The same is true for “Denmark - Regulatory Test Zones for
4 As retrieved from the NIST Glossary, defined in NIST SP 800-160 Vol. 2 Rev. 1, available at:
https://csrc.nist.gov/glossary/term/cyber_resiliency.</p>
        <p>5 As retrieved from the NIST Glossary, defined in NISTIR 8040 under Product (included from ISO 9241-11:1998),
available at: https://csrc.nist.gov/glossary/term/product.</p>
        <p>6 As retrieved from the NIST Glossary, defined in NIST SP 800-34 Rev. 1 under Information System from 44 U.S.C., Sec.
3502, available at: https://csrc.nist.gov/glossary/term/system.</p>
        <p>7 As retrieved from the NIST Glossary, defined in NIST SP 800-160v1r1 (included from ISO 9000:2015), available at:
https://csrc.nist.gov/glossary/term/process.
energy technologies” [UC41], where the measures foreseen include the identification of adequate
protections and risk reduction measures of consumers and companies during the test process – thus,
it is the same risk management activity that is considered in its entirety as a process. A similar
approach may be seen also in the case of “Taiwan - Regulatory sandbox for self-driving vehicles”
[UC43].</p>
        <p>A service may be defined as the “performance of activities, work, or duties”8. This component
includes the testing of specific services before widespread adoption. Testing innovative services can
inform regulatory requirements by highlighting practical challenges and solutions for real-world
applications. This is exemplified by the case of interoperability regulatory sandboxes illustrated in
Subsection 2.1, considering that they focus on the development, training, testing and validation of
innovative interoperability solutions (meant for providing trans-European digital public services).
Moreover, this component is also considered in use cases such as “Jordan - CBJ's FinTech Regulatory
Sandbox” [UC10] (for the identification of the risks associated with the service in scope of
experimentation, together with the definition of a comprehensive risk mitigation plan), or “Australia
- AEMC's Energy Regulatory Sandboxes” [UC40] (which implies the adoption of measures to mitigate
adverse effects on safety, reliability or security of electricity supply).</p>
        <p>In this conceptualisation, the type of technology – such as artificial intelligence or distributed
ledger – is an independent variable, since it is related to the specific projects interested in
participating to the regulatory sandbox. On the other hand, data9 elaboration and protection
represents a cross-component dimension to be duly evaluated and considered within every
regulatory sandbox, depending also on the type of participating project. In this view, it is worth
noticing that data provisioning is an element that is gaining increasing value in the standard
operation of regulatory sandboxes.10</p>
        <p>Incorporating multiple components within this framework could significantly enhance its
capacity to address the complexities of risk management in diverse sectors. By expanding the scope
beyond products to include systems, processes, and services – with data as a cross-component
dimension, and technology as an independent variable – this approach fosters a more comprehensive
and precise assessment of cybersecurity requirements and, in turn, of cyber resilience. Indeed,
cybersecurity requirements should be tested at different levels of abstraction, from single software to
large-scale infrastructure and supporting essential services. The four proposed components thus
allow experimentation at varying levels of complexity, which is essential for the feasibility and
efficacy of cyber resilience regulatory sandboxes.</p>
      </sec>
    </sec>
    <sec id="sec-4">
      <title>4. The 3PS experimentation model</title>
      <p>4.1.</p>
      <sec id="sec-4-1">
        <title>Outlining the working model with respect to contextual cyber risk</title>
        <p>Against this backdrop, a clarification is necessary: the proposed components should be
contextualised with respect to the function that they serve. Experimentation should be tailored
differently with respect to the role that the component will have for the participating entity. Of
course, cyber risk is different for core security components, requiring specific mitigation measures –
and higher assurance levels. In this view, the working model should distinguish at least two
perspectives in which products, systems, processes, and services may be utilized.</p>
        <p>8 As retrieved from the NIST Glossary, defined in NIST SP 800-160v1r1 (included from ISO/IEC/IEEE 15288:2015), avai-l
able at: https://csrc.nist.gov/glossary/term/service.</p>
        <p>9 Data means the “representation of facts, concepts, or instructions in a manner suitable for communication,
interpretation, or processing by humans or by automatic means”, as defined in the NIST Glossary from NIST SP 800-160v1r1, available
at: https://csrc.nist.gov/glossary/term/data.</p>
        <p>10 See, for example, the case of Zurich’s AI Innovation Sandbox which couples regulatory guidance with data
provisioning (visit https://www.innovationsandbox.ai/), the activities of the Datasphere Initiative related to regulatory sandboxes
(visit https://www.thedatasphere.org/), or the African Union’s 2024 Continental AI Strategy (available at
https://au.int/sites/default/files/documents/44004-doc-EN-_Continental_AI_Strategy_July_2024.pdf).</p>
        <p>The first one is the business perspective. Components could be used specifically to achieve
business objectives, thereby fulfilling procedural or operational functions. This involves ensuring
support to day-to-day operations within an organisation or sector. In this case, cybersecurity
requirements are aimed at increasing the safety and correct implementation of these components,
while protecting data and information they may process. This perspective may be appreciated in the
“Bahrain - CBB's Financial Services Regulatory Sandbox” case [UC02], where cybersecurity measures
are undertaken to ensure the safety of the innovative solution or service. It also envisages the
adoption of measures to mitigate major risks, such as business continuity and disaster recovery. The
nature of the solutions in this case is not specified. However, an examination of the register of
previous participants suggests that it predominantly includes business-related components such as
digital trading platforms, cashless tipping solutions, and e-money and crowdfunding platforms.</p>
        <p>The second perspective involves ensuring reliability11. Indeed, components could also be used to
ensure the robustness of digital ecosystems. From a security function, this perspective focuses on
ensuring that products, systems, processes, and services are consistently functioning, even when
confronted with disruptions, incidents, or attacks since they serve basic cybersecurity needs with
respect to the overall architecture. In this second case, cybersecurity serves as a core feature for
ensuring stability of critical infrastructure. Additionally, due to the importance of security
components, the required level of assurance for cybersecurity requirements should be higher: unlike
procedural components, security ones need to provide a reliable degree of resilience in adverse
conditions. This may be the case envisaged by “United Arab Emirates - ADGM's FinTech RegLab”
[UC24], for which the potential of promoting better risk management solutions for the financial
industry may be evaluated when selecting a project for the regulatory sandbox.</p>
        <p>Therefore, the experimentation model should consider both functions in relation to each
component proposed in Subsection 3.2. The 3PS model is thus named after the initials of (P)roducts,
(S)ystems, (P)rocesses and (S)ervices on the one hand, which are foreseen as components of
experimentation; and, on the other hand, of the (P)rocedural and (S)ecurity functions for each one of
them. The functions are “project dependant”, since it is only with a specific component (and its
objective) that such evaluation can be made. This also enriches the carrying out of experimentation,
since it makes it sensitive to the defined context in which the component is deployed.Figure 1 below
illustrates the proposed 3PS experimentation model.</p>
        <p>The 3PS model would allow for the testing and evaluation of multiple components of cyber
resilience, expanding the scope beyond the narrower focus of traditional product safety regulations.
Moreover, while testing one type of component (e.g., product), the competent authority and the
participating entity may agree to experiment with the applicability of cybersecurity requirements in
other connected components (e.g., process). In addition, having a concrete framework of
11 Reliability can be understood as “[t]he ability of a system or component to function under stated conditions for a
specified period of time”, as retrieved from the NIST Glossary, defined in NIST SP 800-160 Vol. 2 Rev. 1 (included from IEEE
Standard Computer Dictionary), available at: https://csrc.nist.gov/glossary/term/reliability.
experimentation allows for more structured regulatory learning: evidence from the regulatory
sandbox could be grouped with respect to the components and functions represented, allowing also
for a more direct comparison of outputs between different schemes.</p>
        <p>To enable a more practical understanding of the model, Table 1 below highlights examples from
the financial services sector, showcasing combinations of components for each envisaged function.</p>
        <sec id="sec-4-1-1">
          <title>PROCEDURAL</title>
        </sec>
        <sec id="sec-4-1-2">
          <title>SECURITY</title>
        </sec>
        <sec id="sec-4-1-3">
          <title>PRODUCT</title>
        </sec>
        <sec id="sec-4-1-4">
          <title>SYSTEM</title>
        </sec>
        <sec id="sec-4-1-5">
          <title>PROCESS</title>
          <p>Mobile banking
apps
Financial market
trading platforms
Account opening
procedures
Fraud detection
software</p>
          <p>Identity
verification
systems (e.g.,
KYC platforms)
Transaction
monitoring
workflows</p>
        </sec>
        <sec id="sec-4-1-6">
          <title>SERVICE</title>
          <p>Wealth
management</p>
          <p>services
Anti-money
laundering</p>
          <p>(AML)
monitoring</p>
          <p>
            The 3PS model may be utilised in different ways with respect to the different stakeholders
involved in the cyber resilience regulatory sandbox. A clarification is needed when it comes to the
main types of actors that are usually involved in the experimentation. In order to have a regulatory
sandbox, two main actors are needed: (i) the regulator (i.e., the competent authority setting up the
scheme), which is in charge of overall supervision and of regulatory guidance; (ii) the innovator (i.e.,
the participating entity), which proposes the project for testing and experimentation, and may be
either public or private. The latter, however, may include both the manufacturer of a specific
component and its deployer, thus the entity actually using it. They may be the same entity in case of
in-house development or be separate in case of an entity acquiring off-the-shelf items for their
networks and infrastructure. Apart from regulators and innovators, regulatory sandboxes may also
include other actors, such as standardisation organisations, testing and experimentation facilities,
research labs, centres of excellence, or individual researchers [cf. Article 58(
            <xref ref-type="bibr" rid="ref2">2</xref>
            ) point (f) AIA].
However, the analysis of their possible role in utilising the 3PS model falls beyond the scope of this
paper.
          </p>
          <p>
            Considering the core stakeholders briefly outlined above, the utilisation of the 3PS model may be
evaluated taking into account two dimensions. First of all, it is important to highlight what
stakeholders could do with the model. In this sense, the latter could support in the structured
definition of sandbox plans, where the scope of experimentation and related requirements, testing
activities, and methodologies are outlined and agreed upon. By using a standardised approach, the
model could simplify and streamline this procedure. On the other hand, it is also key to define what
stakeholders could do within the model. By defining the core structural components of
experimentation, the model could also guide stakeholders when producing evidence and performing
their reporting duties, clearly grouping the collected evidence for better processing. This would
enable a more coherent regulatory learning process, while also supporting structured change
management for participants with respect to the components under experimentation. In this view,
also exit reports – i.e., a document summarising the activities carried out by a project in the
regulatory sandbox [cf. Article 57(
            <xref ref-type="bibr" rid="ref7">7</xref>
            ) AIA] – and cumulative evaluation reports of the overall scheme
could present possible input for policy or regulatory change in an optimised manner.
          </p>
        </sec>
      </sec>
      <sec id="sec-4-2">
        <title>Evaluating CRA’s essential cybersecurity requirements</title>
        <p>A main starting point for any cyber resilience regulatory sandbox lies in the essential cybersecurity
requirements described in Annex I of the CRA. These requirements not only set the baseline for
compliance but also shape the framework for testing and experimentation. Understanding how they
integrate with the components defined above is therefore essential for designing effective and
adaptive experimentation environments.</p>
        <p>While the CRA focuses on products with digital elements, cybersecurity practices extend far
beyond this scope, embodying a holistic approach that transcends product safety alone. This is the
case also for the essential cybersecurity requirements foreseen in the CRA. Therefore, it is important
to understand how these requirements apply to products, systems, processes and services.</p>
        <p>
          With respect to products, key requirements pertain to:
 Secure design and development. Products with digital elements should be designed,
developed and produced to ensure an appropriate level of cybersecurity with respect to
the specific risks they face [Part I(
          <xref ref-type="bibr" rid="ref1">1</xref>
          ) of Annex I CRA].
 Default configurations. Products should be made available with secure-by-default settings
and allow a reset to original state [Part I(
          <xref ref-type="bibr" rid="ref2">2</xref>
          ) point (b)].
 Data confidentiality and integrity. Data confidentiality should be protected by applying at
rest or in transit encryption [Part I(
          <xref ref-type="bibr" rid="ref2">2</xref>
          ) point (e)]. Data integrity should be protected against
any manipulation or modification [Part I(
          <xref ref-type="bibr" rid="ref2">2</xref>
          ) point (f)].
        </p>
        <p>
          With respect to systems, key requirements pertain to:
 Access control. Authentication, identity or access management systems should be adopted
[Part I(
          <xref ref-type="bibr" rid="ref2">2</xref>
          ) point (d)].
 Interconnected systems’ integrity. Products should minimize possible negative impacts on
connected networks and devices [Part I(
          <xref ref-type="bibr" rid="ref2">2</xref>
          ) point (i)].
 Dependencies’ mapping. A software bill of materials should be maintained, also by tracking
top-level dependencies [Part II(
          <xref ref-type="bibr" rid="ref1">1</xref>
          )].
        </p>
        <p>
          With respect to processes, key requirements pertain to:
 Risk assessment. A cybersecurity risk assessment should be performed to address
identified risks [Part I(
          <xref ref-type="bibr" rid="ref2">2</xref>
          )].
 Vulnerability handling. Vulnerabilities should be identified and remediated without delay
[Part II(
          <xref ref-type="bibr" rid="ref1">1</xref>
          ) and (
          <xref ref-type="bibr" rid="ref2">2</xref>
          )]. Regular security tests and reviews should be conducted [Part II(
          <xref ref-type="bibr" rid="ref3">3</xref>
          )]. A
policy for coordinated vulnerability disclosure should be defined and enforced [Part II(
          <xref ref-type="bibr" rid="ref5">5</xref>
          )].
 Incident handling. Measures should be implemented to reduce incident impacts [Part I(
          <xref ref-type="bibr" rid="ref2">2</xref>
          )
point (k)] and maintain availability of services [Part I(
          <xref ref-type="bibr" rid="ref2">2</xref>
          ) point (h)].
        </p>
        <p>
          With respect to services, key requirements pertain to:
 Security updates. Automatic and timely updates should be addressed and, where
applicable, enabled by default [Part I(
          <xref ref-type="bibr" rid="ref2">2</xref>
          ) point (c]. Mechanisms for securely distributing
updates and mitigating vulnerabilities should be provided [Part II(
          <xref ref-type="bibr" rid="ref7">7</xref>
          )].
 User guidance. Product users should be notified of relevant updates, advisory messages,
and possible mitigation actions [Part II(
          <xref ref-type="bibr" rid="ref8">8</xref>
          )].
 Vulnerability information sharing. Details on fixed vulnerabilities should be shared,
together with clear remediation steps [Part II(
          <xref ref-type="bibr" rid="ref4">4</xref>
          )]. Channels for receiving and
disseminating information about vulnerabilities should be established [Part II(
          <xref ref-type="bibr" rid="ref4">4</xref>
          )].
        </p>
        <p>In conclusion, starting from requirements on the specific product, this Regulation also entails
controls that are applicable to the other components considered: to have safe and secure products
with digital elements in the European market involves also testing requirements on connected
systems, processes and services. However, these requirements are designed to functionally support
and enhance the security of the product under experimentation. Hence, in this case, the basis is
always product driven. Moreover, to understand the applicability of the model in evaluating the
CRA’s essential cybersecurity requirements across the procedural and security functions, it is
fundamental to follow real cases of experimentation within regulatory sandboxes.</p>
      </sec>
    </sec>
    <sec id="sec-5">
      <title>5. Conclusion and future work</title>
      <p>This paper aims to bridge a research gap on how sandboxes could become regulatory sandboxes to
enhance cyber resilience. While they are referred to in several EU directives and regulations, such as
the Interoperable Europe Act, the Artificial Intelligence Act, and the Cyber Resilience Act, there is
limited research that embodies the utilization of shared models or frameworks that can result in
experimentation within the safe environment in a bid to apply and test appropriate cybersecurity
requirements.</p>
      <p>Here, the article introduces an experimentation framework called the 3PS model. The initial
analysis used 43 use cases from various industries and demonstrated that regulatory sandboxes can
be employed as effective tools for testing and implementing risk management strategies. The
research revealed that risk management in regulatory sandboxes encompasses a broad range of
activities beyond traditional product-oriented applications. Thus, the paper sets out the basic
constituents of risk management based on a use case analysis and suggests four basic components
which are essential to the model: products, systems, processes, and services. They have a twofold
nature: they might be expressly designed for business-related functions or with the objective to
facilitate or aid organizational functioning's dependability. Thus, the four elements which were
identified might have two possible roles—a procedural role and a security role. Thus, the 3PS model is
framed by considering the elements (P)roduct, (S)ystem, (P)rocess, and (S)ervice into their two
respective roles (P)rocedural and (S)ecurity. Some of the possible real-life solutions for every
situation have also been explained. The model envisioned not only bridges a concept gap in
describing how cybersecurity requirements might be tested within regulatory sandboxes but also
encompasses the broader exigences of policymakers under the likes of the Cyber Resilience Act, an
additional analysis on which has been performed in terms of the cybersecurity requirements that are
considered necessary pursuant to it.</p>
      <p>The model should serve as a template for future regulatory sandboxes, particularly cyber
resilience ones. Future research must advance in three areas to build on this work. First, one must
conduct a comprehensive examination of relevant EU-level regulations (such as the NIS2 Directive)
in order to gather additional cybersecurity mandates and insert them into the 3PS model, ensuring
adaptability to evolving regulatory environments and potential enhancement of the model. This
would facilitate cross-regulation testing and implementation, an emerging issue in regulatory
sandboxes. A contextualised examination would also evaluate national norms of cybersecurity,
sectoral regulation and nuanced cybersecurity controls for a better understanding of all the layers
applicable to the chosen component. Second, attention should be paid to observing cases of
cybersecurity testing in operational regulatory sandboxes, employing as well the 3PS model.
Examining these real-world cases could help in identifying challenges, best practices, and loopholes
in the proposed 3PS model, and verify its efficacy. Finally, there should be an attempt at mapping
admitted projects within regulatory sandboxes to the 3PS model matrix. This would increase the
conceptual basis of the model by providing concrete examples for all categories of components and
functions. In general, these directions aim to develop knowledge in cybersecurity experimentation,
enhance the useability of the 3PS model, and inform the development of cyber resilience regulatory
sandboxes for future initiatives.</p>
      <p>Declaration on Generative AI
The author has not employed any Generative AI tools.</p>
      <p>Appendix</p>
      <p>Financial services (31 occurrences)
[UC01] Austria - FMA's Financial Identification of possible threats to financial market
Services Sandbox stability or consumer protection.
(more information available at:
https://www.fma.gv.at/en/fintech-point-ofcontact-sandbox/fma-sandbox/)12
[UC02] Bahrain - CBB's Financial
Services Regulatory Sandbox
(more information available at:
https://www.cbb.gov.bh/fintech/)</p>
      <p>Cybersecurity and other relevant measures to be
undertaken to ensure safety of the innovative solution or
service.</p>
      <p>Identification of major risks associated with the innovative
solution or service, including measures to mitigate these
risks, such as business continuity and disaster recovery.</p>
      <p>12 All links have been last accessed on 19 February 2025. Unavailable direct links have been retrieved through Internet
Archive’s Wayback Machine service.
[UC03] Brazil - BCB's Financial
Services Regulatory Sandbox
(more information available at:
https://www.bcb.gov.br/en/
financialstability/regulatorysandbox)
[UC04] Hong Kong - HKIA's
Insurtech Sandbox
(more information available at:
https://www.ia.org.hk/en/aboutus/
insurtech_corner.html#1)
[UC05] Hong Kong - HKMA's
Fintech Supervisory Sandbox
(more information available at:
https://www.hkma.gov.hk/eng/keyfunctions/international-financial-centre/
fintech/fintech-supervisory-sandbox-fss/)
[UC06] Hong Kong - SFC's
Financial Services Regulatory
Sandbox
(more information available at:
https://www.sfc.hk/en/Welcome-to-theFintech-Contact-Point/SFC-RegulatorySandbox)
[UC07] India - RBI's Financial
Services Regulatory Sandbox
(more information available at:
https://rbi.org.in/scripts/
PublicationReportDetails.aspx?ID=1262)
[UC08] Indonesia - FSA's Digital
Finance Innovation Initiative
(more information available at:
https://web.archive.org/web/
20230614121758/https://www.ojk.go.id/
iru/BE/uploads/regulation/files/
file_35a2beef-e4c8-4ca8-8f42-4cfc0f18024607092022161630.pdf)
[UC09] Italy - Financial Services
Regulatory Sandbox
(more information available at:
https://www.bancaditalia.it/focus/
sandbox/index.html?com.dotmarketing.
htmlpage.language=1)
Assessment of the nature and magnitude of the risks
inherent to the innovative project.</p>
      <p>Implementation of a structure for risk management, that
allows for identification, measurement, evaluation,
monitoring, reporting, control and mitigation operational,
credit and other relevant risks.</p>
      <p>Adoption of adequate safeguards for protecting the
interests of customers during the trial.</p>
      <p>Adoption of risk management controls and control
procedures to achieve the objectives of the relevant
supervisory requirements.</p>
      <p>Adoption of measures for protecting the interests of
customers during the trial.</p>
      <p>Adoption of risk management controls for lack of full
compliance possible negative effects posed to the financial
system and customers.</p>
      <p>Implementation of adequate investor protection measures
to address actual or potential risks or concerns identified
when they operate in the regulatory sandbox.</p>
      <p>Implementation of measures in compliance with existing
norms on consumer data protection and privacy.</p>
      <p>Adoption of adequate built-in safeguards for IT systems to
protect against unauthorized access, alteration,
destruction, disclosure or dissemination of records and
data.</p>
      <p>Assessment and mitigation of significant risks arising
from the proposed solution or service.</p>
      <p>Compliance with consumer protection and data protection
rules.</p>
      <p>Improvement of the risk management systems, procedures
and processes for banking, financial or insurance
operators: optimization in terms of cost and/or internal
resources, increased effectiveness in identifying and/or
measuring and managing risks.
[UC10] Jordan - CBJ's FinTech
Regulatory Sandbox
(more information available at:
https://www.cbj.gov.jo/EN/Pages/
Regulatory_laboratory)
[UC11] Malaysia - BNM's Financial
Services Regulatory Sandbox
(more information available at:
https://www.bnm.gov.my/sandbox)
[UC12] Malta - MFSA's FinTech
Regulatory Sandbox
(more information available at:
https://www.mfsa.mt/fintech/regulatorysandbox/)
[UC13] Mauritius - FSC's Financial
Services Regulatory Sandbox
License
(more information available at:
https://www.fscmauritius.org/
media/167529/regulatory-sandboxguidelines.pdf)
[UC14] Mauritius - MEDB's
Regulatory Sandbox License
(more information available at:
https://edbmauritius.org/wp-content/uploads
/2022/06/Consult-the-Guidelines-to-applyfor-a-Regulatory-Sandbox-Licence-forFintech-Projects.pdf)
[UC15] Nigeria - CBN's Regulatory
Sandbox
(more information available at:
https://web.archive.org/web/
20240725232213/https://
sandbox.cbn.gov.ng/)
[UC16] Oman - CBO's Fintech
Regulatory Sandbox Framework
(more information available at:
https://cbo.gov.om/sites/assets/
Documents/English/Fintech/
FRSProposalFramework.pdf)
[UC17] Philippines - BSP's
Financial Services Regulatory
Sandbox
(more information available at:
https://www.bsp.gov.ph/
Regulations/Issuances/2022/1153.pdf)
Application of terms and conditions to ensure consumer
protection, rights of consumers, and to maintain the
integrity and financial stability.</p>
      <p>Identification of the risks associated with the solution or
service and definition of a comprehensive risk mitigation
plan.</p>
      <p>Demonstration of ability to identify and mitigate risks
associated with the proposed solution (considering scale of
the project and nature of risks).</p>
      <p>Identification of potential risks to financial institutions
and consumers stemming from the testing; proposal of
appropriate safeguards to address the identified risks.</p>
      <p>Definition of a dedicated plan accounting for possible
risks, demonstrating the existence of a suitable mitigation
plan which ensures consumer protection, market integrity
and financial soundness.</p>
      <p>Existence of a proper risk management strategy that
incorporates appropriate safeguards to mitigate potential
risks, control their impact, and address possible failures
effectively.</p>
      <p>Proposal of adequate safeguards, and specific terms and
conditions to mitigate foreseeable risks associated with
the project.</p>
      <p>Limitation of transactions’ value and volume for better
risk management and mitigation.</p>
      <p>Evaluation of potential risks and planned mitigation
measures, including an emergency exit strategy for cases
where live testing fails or is terminated due to
noncompliance.</p>
      <p>Outline of safeguards to protect customers, offering
necessary guarantees and compensation.</p>
      <p>Adoption of measures to protect the rights and interests of
consumers during the experimentation.</p>
      <p>Identification of significant risks (including IT and
cybersecurity, data integrity and data privacy, and
consumer protection) and of safeguards and risk
mitigation strategies.
[UC18] Qatar - CBQ's FinTech
Sandbox &amp; Licensing Registration
Platform
(more information available at:
https://sandbox.qcb.gov.qa/login)
[UC19] Saudi Arabia - SAMA's
Open Banking Regulatory Sandbox
(more information available at:
https://www.sama.gov.sa/en-US/Regulatory%
20Sandbox/
Documents/Regulatory_Sandbox_
Framework_English-NOV2020.pdf)
[UC20] Singapore - MAS's FinTech
Regulatory Sandbox
(more information available at:
https://www.mas.gov.sg/development/
fintech/regulatory-sandbox)
[UC21] South Korea - FSC's
Financial Services Regulatory
Sandbox
(more information available at:
https://sandbox.fintech.or.kr/?lang=en)
[UC22] Spain - Financial Services
Regulatory Sandbox
(more information available at:
https://www.tesoro.es/en/sandbox/
solicitudes-para-el-espacio-controlado-depruebas)
[UC23] Taiwan - FSC's Financial
Technology Innovative
Experimentation
(more information available at:
https://law.moj.gov.tw/ENG/
LawClass/LawAll.aspx?pcode=G0380254)
[UC24] United Arab Emirates
ADGM's FinTech RegLab
(more information available at:
https://www.adgm.com/setting-up/fintech)
Preparation of risk analysis and a corresponding risk
mitigation plan.</p>
      <p>Identification and addressing of any risks for consumers
and markets resulting from the proposed innovation
(comprehensive risk assessment and mitigation plan).</p>
      <p>Definition of appropriate boundary conditions for
experimenting while maintaining consumer protection,
and market safety and soundness.</p>
      <p>Assessment and mitigation of significant risks arising
from the proposed solution or service.</p>
      <p>Assessment of measures to ensure the security and
privacy of consumer information, and consumer
protection at large.</p>
      <p>Determination of the robustness of the risk management
framework, including measures to mitigate financial and
operational risks.</p>
      <p>Assessment of the potential systemic risks posed by the
proposed solution or service; evaluation of the project’s
impact on the integrity of the financial market.</p>
      <p>Evaluation of the impact of the project on the financial
system.</p>
      <p>Identification of protection measures for participants.</p>
      <p>Assessment of potential risks and preparation of relevant
response measures.</p>
      <p>Identification of potential to promote better risk
management solutions for the financial industry.</p>
      <p>Existence of a regulatory plan, setting out activities,
internal controls and resources to address identified risks.</p>
      <p>Adoption of safeguards with respect to associated risks
and the type of clients potentially impacted by the
proposed solution or service.
[UC25] United States - Florida's
Financial Technology Sandbox
Innovator
(more information available at:
https://flofr.gov/sitePages/
FinancialTechnologySandbox.htm)
[UC26] United States - Kentucky's
Insurance Regulatory Sandbox
(more information available at:
https://casetext.com/statute/kentuckyrevised-statutes/title-25-business-andfinancial-institutions/chapter-304-insurancecode/subtitle-3043-authorization-of-insurersand-general-requirements/regulatorysandbox)
[UC27] United States - Nevada's
Financial Services Sandbox
Program
(more information available at:
https://business.nv.gov/Programs/
Nevada_Sandbox_Program/)
[UC28] United States - North
Carolina's Financial and Insurance
Regulatory Sandbox
(more information available at:
https://www.innovation.nc.gov/)
[UC29] United States - Vermont's
Insurance Regulatory Sandbox
(more information available at:
https://dfr.vermont.gov/industry/
insurance/regulatory-sandbox)
[UC30] United States - West
Virginia's FinTech Sandbox
(more information available at:
https://dfi.wv.gov/fintech/Pages/
default.aspx)
[UC31] United States - Wyoming's
Financial Technology Sandbox
(more information available at:
https://wyomingbankingdivision.wyo.gov/
banks-and-trust-companies/financialtechnology-sandbox)
Evaluation of the potential risk to consumers, including
the methods that will be used to protect consumers and
resolve complaints during the experimentation.</p>
      <p>Evaluation of how the innovation provides suitable
consumer protection and not pose an unreasonable risk of
consumer harm.</p>
      <p>Evaluation of the ability to conduct experimentation that
does not place undue risk on consumers.</p>
      <p>Identification of the methods used to protect consumers
during the experimentation.</p>
      <p>Assessment of risks such as the experimentation does not
substantially or unreasonably increase any risk to
consumers.</p>
      <p>Identification of possible risks to consumers in relation to
the innovative product or service.</p>
      <p>Definition of risk mitigation measures to limit potential
harm to consumers.</p>
      <p>Identification of potential risk to consumers and of risk
mitigation methods to protect consumers during
experimentation.
[UC32] France - France
Experimentation
(more information available at:
https://www.modernisation.gouv.fr/
transformer-laction-publique/franceexperimentation)
[UC33] Italy - Italy
Experimentation
(more information available at:
https://innovazione.gov.it/progetti/
sperimentazione-italia/)
[UC34] Malta - MDIA's Technology
Assurance Sandbox
(more information available at:
https://web.archive.org/web/
20240522201002/https://mdia.gov.mt/
technology-assurance-sandbox/)
[UC35] Portugal - Free Zones for
Technology
(more information available at:
https://portugaldigital.gov.pt/en/
accelerating-digital-transition-in-portugal/te
sting-and-incorporating-new-technologies/
technological-free-zones-zlt/)
[UC36] Saudi Arabia - CST's
Emerging Technologies Regulatory
Sandbox
(more information available at:
https://www.cst.gov.sa/en/services/
Pages/Emerging_Technologies_
sandbox.aspx)
[UC37] Spain - AI Regulatory
Sandbox Pilot Scheme
(more information available at:
https://www.boe.es/buscar/
doc.php?id=BOE-A-2023-22767)
[UC38] United Arab Emirates
RegLab
(more information available at:
https://reglab.gov.ae/)</p>
      <p>Cross-sectoral (8 occurrences)</p>
      <p>Development of a detailed framework to evaluate the
exemption's impact, including defining data collection and
transmission protocols for assessing associated risks and
the methods used.</p>
      <p>Identification of mitigation measures for potential
additional risks; establishment of a plan for
postimplementation evaluation of socio-economic effects, such
as economic, environmental, health, and safety outcomes
(ensuring a comprehensive risk assessment).</p>
      <p>Adoption of requirements deemed necessary to mitigate
the risks connected to the experimentation.</p>
      <p>Identification and assessment of risks in terms of impact,
severity, and probability of occurrence, including
mitigation plans against the identified risks.</p>
      <p>Definition of a monitoring plan for the tests to be carried
out.</p>
      <p>Drawing up an adequate risk assessment and a clear risk
mitigation strategy.</p>
      <p>Identification and addressing of any risks for consumers
and markets resulting from the proposed innovation
(comprehensive risk assessment and mitigation plan).</p>
      <p>Evaluation of the relative and absolute impact on economy
and society of general-purpose AI models; evaluation of
their potential to be transformed into high-risk AI
systems.</p>
      <p>Evaluation of compliance with rules on personal data
protection.</p>
      <p>Identification of risks associated with testing or
implementing the proposed solution or service.</p>
      <p>Definition of a risk management plan.
[UC39] United Arab Emirates
TDRA's ICT Regulatory Sandbox
[UC40] Australia - AEMC's Energy
Regulatory Sandboxes
[UC41] Denmark - Regulatory Test
Zones for energy technologies</p>
      <p>Definition of detailed risk management strategies.</p>
      <p>Energy (2 occurrences)
Adequate consumer protection in connection with the
trial project.</p>
      <p>Measures to mitigate adverse effects on AEMC’s operation
of the power system and market.</p>
      <p>Measures to mitigate adverse effects on safety, reliability
or security of electricity supply.</p>
      <p>Identification of adequate protections and risk reduction
measures of consumers and companies during the test
process (e.g., financial and supply-related risks).</p>
      <p>Transportation (2 occurrences)</p>
      <p>Performance of a route analysis and risk assessment for
the planned test route or the planned test area; results to
be incorporated into risk management for the test plan.</p>
      <p>Identification and prevention of further risk requirements
through a risk analysis for the entire test project.</p>
    </sec>
  </body>
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