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  <front>
    <journal-meta>
      <issn pub-type="ppub">1613-0073</issn>
    </journal-meta>
    <article-meta>
      <title-group>
        <article-title>AI Development: Ensuring Data Protection and Ethics</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Maria Catarina Batista</string-name>
          <email>catabatista1999@gmail.com</email>
          <xref ref-type="aff" rid="aff0">0</xref>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Workshop</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>NOVA School of Law</institution>
          ,
          <addr-line>Lisbon</addr-line>
          ,
          <country country="PT">Portugal</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>Synthetic Data</institution>
          ,
          <addr-line>AI, GDPR, Data Protection, Ethics, Data Governance</addr-line>
        </aff>
      </contrib-group>
      <abstract>
        <p>The generation and use of synthetic data have transformed AI system development, enabling a shift from reliance on real-world data to artificial data that preserves the statistical properties of real data while mitigating privacy concerns. As a Privacy Enhancing Technology, data synthesis strikes a balance between data protection mandates and data utility. However, synthetic data introduces ethical challenges, such as bias, misinformation, and public distrust, which this study addresses. This paper emphasizes the necessity of urgent measures to uphold public trust in AI systems and ensure the responsible use of synthetic data in research, especially in sensitive areas like healthcare. It evaluates the British perspective on synthetic data use in research, presenting it as an initial approach to these challenges.</p>
      </abstract>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>1. Introduction</title>
      <p>Back in the day, data used for research were mostly collected from sources in the physical world,
encompassing a wide range of information. However, with the generation of synthetic data, this
scenario has sufered radical changes. This paper examines the impact of using synthetic data to train
AI systems on privacy and ethics in our society. In the first section, key concepts around data synthesis
are delineated. In section two, we explore issues such as bias, loss of public trust, and the principle
of data accuracy, with a practical scenario involving health data accuracy. The third section assesses
the British perspective on the use of synthetic data for research. Finally, the fourth section draws
conclusions and outlines future approaches to ethical standards for the use of synthetic data .</p>
      <p>
        For the purpose of this paper, data obtained from real-world sources to generate synthetic data
are referred to as ”real data”. When this data is related to an identified or identifiable natural person,
they are categorized as ”personal data”, as per Article 4 (1) of the General Data Protection Regulation
(“GDPR”) [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ].
      </p>
      <p>
        According to Dr Khaled El Emam, a leading figure on data synthesis and anonymization, at a
conceptual level, synthetic data can be defined as “data that has been generated from real data and that
has the same statistical properties as the real data” [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. This definition recognizes the artificial nature of
synthetic data while retaining the statistical characteristics of the real data. It is crucial to understand
that synthetic data refers to data that is artificially created to mimic the patterns and insights found in a
real dataset without directly copying information about the individuals represented in that dataset [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ].
This type of data can be produced either by using an actual dataset or through deductions and rules
established by the coder.[
        <xref ref-type="bibr" rid="ref3">3</xref>
        ] [4] Such inferences can be drawn from AI systems, or via human analysis,
contingent on the variables present within the source dataset [4].
      </p>
      <p>Data synthesis is a Privacy Enhancing Technology (“PET”) that has been developed as a promising
solution to address Data Protection concerns while enabling valuable insights to be extracted from real
data [5]. The imperatives of privacy dictate that synthetic data should not solely repeat the statistical
patterns and correlations of the real data used for the data synthesis procedure. The GDPR and other
Spain</p>
      <p>CEUR</p>
      <p>ceur-ws.org</p>
      <p>
        Data Protection frameworks demand an inherent trade-of between the safeguarding of data subjects
and the practical utility of such data [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. This trade-of is quantified by measuring the accuracy of the
synthetic data in relation to the real data [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. The higher the degree of privacy preservation incorporated,
the more likely the synthetic data is to diverge from the statistical relationships present in the real
data, thus having lower utility [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. This balancing test is crucial in scenarios where the preservation of
certain attributes from the real data, for example for analytical accuracy and reliability, is necessary to
achieve the purpose for which the synthetic data was generated [6]. For instance, if the purpose of the
data synthesis is to generate synthetic data to train AI models for consumer prediction, the demand
for high utility is superior [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. In opposition, when data synthesis’ purpose is to assess a software’s
capability to manage an extensive volume of transactions, the interest in the utility of such data would
be significantly reduced [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ].
      </p>
      <p>In short, by examining the balance between data protection and utility, especially within the
framework of GDPR, we underscore the importance of maintaining data accuracy while safeguarding
individual privacy. The next section of this paper aims to provide a comprehensive understanding of the
responsible use of synthetic data in AI systems. packages.</p>
    </sec>
    <sec id="sec-2">
      <title>2. Unveiling the Challenges and Risks in AI Systems Using Synthetic</title>
    </sec>
    <sec id="sec-3">
      <title>Data</title>
      <p>Over recent years, data synthesis has developed into a refined tool that efectively tackles both privacy
and accuracy issues in settings that rely heavily on data [5]. In 2020, Gartner acknowledged the
significance of synthetic data, advising organizations to incorporate it into their overall data strategies [7].
They pointed out its scalable nature and compliance with privacy standards, underscoring its broad
applicational potential [7]. By 2024, the use of synthetic data has expanded significantly, with both
commercial enterprises and governmental institutions leveraging it to advance research, enhance
services, and improve decision-making processes [6]. Nevertheless, it also holds significant accountability
issues and ethical challenges, as it will be demonstrated in the following subsections.</p>
      <sec id="sec-3-1">
        <title>2.1. Bias and Loss of Public Trust</title>
        <p>Data synthesis is a technique that has the potential of enhancing the reproducibility and diversity of a
dataset, thus, it can be used as a tool to reduce biases in datasets [8]. In the context of AI development,
synthetic data generation enables the creation of edge cases and fills in missing data. This approach
helps to address potential biases and inaccuracies in the input datasets, which are crucial for training
models. By incorporating these diverse scenarios, synthetic data ensures that the models are more
robust and less likely to produce harmful biased outputs.[8].</p>
        <p>While having the potential to protect disadvantaged groups from harmful bias present in datasets, the
use of data synthesis brings to the table many ethical challenges, such as synthetic media and deepfakes,
enhancing the risks of misinformation and societal distrust [6]. It is essential to understand that the
absence of information about the source and quality of synthetic data introduces a major challenge:
discerning which information within the dataset is valid and which is not [9].</p>
        <p>Synthetic media, which is a subset of synthetic data, focusing specifically on media content created
using AI techniques, is a great example of the ethical concerns previously mentioned, since its main
function is to replicate real-world content, such as images, videos, or audio [10]. Increasingly recognized
for its problematic aspects in society, ”deepfakes” involve manipulated media where images and videos
are altered to falsely depict individuals saying or doing things they never actually did [10]. For instance,
deepfakes involving fake sexual photos represent a severe violation of privacy and consent, intensifying
ethical issues within synthetic media [10, 11]. Therefore, in this case, synthetic data’s capacity for
misrepresentation damages reputations, leads to misleading perceptions, and can cause significant
emotional distress [12].</p>
        <p>The widespread creation and distribution of synthetic media contribute to societal distrust in media,
further eroding social cohesion and heightening public scepticism towards legitimate information.
This, in turn, poses challenges for maintaining trust in digital communications and media integrity
[10]. Furthermore, synthetic data can lead to cases of mistaken identity. For instance, when creating
a synthetic persona, it is possible that this fake person could be mistaken for a real person from the
dataset used to generate the synthetic data [10].</p>
        <p>While there appears to be no straightforward solution for synthetic data generated with malicious
intent, it is possible to manage some ethical issues like bias and misrepresentation, through the
implementation of risk mitigation measures previously and during the data synthesis procedure. Thus, in the
next session we go through practical scenarios to evaluate the legal and ethical dimensions in synthetic
data use cases and we provide our input to improve the compliance of such processing activities.</p>
      </sec>
      <sec id="sec-3-2">
        <title>2.2. Principle of Data Accuracy</title>
        <p>The principle of data accuracy, enshrined in Article 5(1)(d) of the GDPR, embodies the trustworthiness
and reliability of the Data Subjects in the processing of Personal Data [13]. According to the GDPR,
controllers and processors should maintain the precision of datasets and must immediately rectify any
inaccuracies when they arise. However, the processing of synthetic data introduces a complex layer
to this issue. Synthetic data, being an artificial construct, does not directly represent real individuals.
From a Data Protection compliance perspective, it raised an important question: How can accuracy be
ensured in synthetic data, which lacks a direct link to the individuals?</p>
        <p>
          It is necessary to point out that once the synthetic data has been generated, the next step of the data
synthesis procedure involves calculating its metrics [
          <xref ref-type="bibr" rid="ref2">2, 14</xref>
          ]. These metrics are then compared with
those of the real data using a tool known as a discriminator [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. This discriminator evaluates the utility
of the synthetic data by examining whether its statistical properties closely mirror those of the real data
[
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. During this metrics calculation phase, synthetic data developers are responsible for ensuring that
the statistical patterns and correlations present in the real data are accurately replicated in the artificial
data [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. This ensures that the synthetic data maintains fidelity to the real data it represents [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. Thus,
when the comparison reveals that the synthetic data diverges from the real data, adjustments should
be made to the generation parameters and a new and accurate dataset should be produced [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. This
process must be repeated until achieving accurate synthetic data [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ].
2.2.1. Practical Case: Health Data Accuracy
This subsection highlights the vital role of synthetic data in enhancing healthcare through a practical
perspective. AI systems, which demand extensive and accurate training data, are increasingly being
employed in healthcare for various purposes, such as medical imaging, patient data analytics, and drug
discovery [6, 15, 16]. A common issue in clinical trials is the inaccurate gender distribution among
participants. For instance, when there is the predominance of male participants in a drug trial, it
hinders the understanding of the medication’s efects on females [ 17]. To face this issue, synthetic data,
generated specially to replicate the health profiles typical of female participants, can be integrated into
the analysis to create a more inclusive and balanced study [18]. Thus, synthetic data can be used as a
strategic feature to improve the performance and reliability of AI systems to generate better informed
results [6].
        </p>
        <p>However, the use of not well-produced synthetic data might diminish societal trust in research,
leading to doubts about the authenticity and integrity of a trial’s findings [ 15]. When using poor
generated synthetic data to represent a demographic insuficiently represented in the real trial, such
data might lead to potential inaccuracies in understanding how the medication afects that specific
group, leading to erroneous medical decisions, with dangerous consequences for real patients [6].</p>
        <p>From an ethical stance, the use of synthetic data not only helps achieve an unbiased dataset but
also supports broader demographic research, in any field of study [ 6]. Nevertheless, regardless of the
precautionary measures taken by developers, researchers must be aware that there is always the risk
that errors in the synthetic data generation may occur [6] Therefore, when processing synthetic data,
analysts and researchers must always proceed with caution, acknowledging that there is the possibility
that not every pattern or correlation observed might be accurate.</p>
        <p>A prime example of synthetic data’s limitation is the partial synthesis of survey data collected by
the Cancer Care Outcomes Research and Surveillance (”CanCORS”) project [19]. In this instance,
after evaluating the synthetic data created using the project’s model, researchers determined that
the dataset was suitable only for preliminary data analysis due to problems with data correlations
[6, 19]. Consequently, it is essential for developers of synthetic data to maintain transparency about the
dataset’s quality and clearly communicate its limitations to end-users.</p>
        <p>
          Although some synthetic datasets as CanCORs can only be used for preliminary data analysis, they
can still ofer significant value at this early stage of research. For example, synthetic data provides
a safe, eficient, and flexible alternative to using real data during software testing [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ]. Furthermore,
incorporating synthetic data in the development phase can expedite the software refinement process
and reduce computational demands, due to its high-quality labelling [
          <xref ref-type="bibr" rid="ref2">2</xref>
          ].
        </p>
        <p>By incorporating synthetic data in the early stages of model development, the use of real data is
deferred until the software’s security has been verified. This strategy efectively reduces the risks
associated with data processing, such as data breaches, thus enhancing the protection of the
confidentiality, integrity, and availability of personal data [6]. Moreover, this method highlights the role
of synthetic data in facilitating research advancements while simultaneously bolstering data security.
This approach is particularly relevant for special categories of personal data, such as health data, where
the fundamental right to data protection demands special attention.</p>
      </sec>
    </sec>
    <sec id="sec-4">
      <title>3. From Theory to Practice: How the UK Implements Synthetic Data</title>
    </sec>
    <sec id="sec-5">
      <title>Strategies</title>
      <p>In this section, we assess how synthetic data is being approached from a policy-making perspective. As
mentioned in the previous sections, the use of synthetic data raises critical implications for transparency
and communication to individuals [20]. When presenting research findings based on synthetic data,
it becomes crucial to ensure that audiences are made highly aware of this combination of data [9].
Recognizing the gravity of these concerns, bodies like the UK Statistics Authority and the Ofice
for National Statistics (“ONS”) have taken proactive steps, formulating comprehensive guidelines on
synthetic data [21].</p>
      <p>The ONS Synthetic Data Policy stresses key legal and ethical issues, such as confidentiality and data
disclosure risks, ofering an essential framework for responsible synthetic data processing in statistical
research [21]. This Policy determines the ethical handling of synthetic data in research and analysis,
ensuring compliance with legal standards and reducing potential liabilities. This Policy is particularly
significant as it marks the first documented guideline for managing synthetic data, thus providing
orientation for researchers and analysts across all jurisdictions [21].</p>
      <p>The UK Statistics Authority also established comprehensive guidance on synthetic data, including
an overview of ethical considerations and mitigation strategies and an ethics checklist [22, 23]. This
Authority has also developed ethical principles and an ethics self-assessment tool to guide researchers
and statisticians in addressing ethical issues in various projects, including those involving synthetic
data [23, 24]. Such principles emphasize the public good, data confidentiality, risk assessment, legal
compliance, public perception, and transparency in data collection and usage [23, 24]. Therefore, by
consistently incorporating a thoughtful ethical framework into each project, it is possible to address
these concerns, ensuring both the integrity of the research and the continued trust of individuals in
data synthesis [6].</p>
      <p>Moreover, the Authority demonstrates the prominent need to balance utility, which is the data’s
practical usefulness, and fidelity, its authenticity [ 22]. Such a balance is a parameter that demonstrates
the eficiency of synthetic data to serve its intended purpose while accurately representing the real data
[22]. Essentially, utility represents if synthetic data satisfies specific research or analytical purposes [ 22].
Conversely, synthetic data retaining substantial fidelity accurately reflects the attributes of real data,
consequently serving as an accurate alternative for the real data [22]. A mirror reflecting a complex
scene can exemplify fidelity; the clearer the reflection, the higher the fidelity [ 22]. High-fidelity datasets
are very detailed and closely mimic real-world data, thus they are very useful for complex tasks like
developing new medical treatments or training advanced AI models to predict patient outcomes. On
the one hand, if synthetic data mirrors too closely the real data, it could inadvertently reveal personal
data through inference, thus violating Data Protection norms and ethical considerations [22]. On the
other hand, if synthetic data deviates too much from the real dataset, its utility for research might be
compromised due to a lack of authenticity [22]. In opposition, low fidelity datasets are less detailed
and more generalized, thus having a lower risk of revealing personal data, making it safer to use for
research [22]. Low-fidelity datasets are also particularly useful for gaining a broad understanding of
trends and patterns in research without delving into sensitive details.</p>
      <p>Finally, the importance of these British guidelines lies in their function as a standard for ideal data
management practices in the world while the statistical research industry is in harmony with wider
legal norms like the European and UK GDPR. Therefore, by adhering to these guidelines, organizations
and researchers will comply with legal mandates related to Data Protection, thereby reducing legal
risks associated with the use and management of Synthetic Data, while also upholding societal ethical
principles.</p>
    </sec>
    <sec id="sec-6">
      <title>4. Conclusion</title>
      <p>The exploration of synthetic data within the field of artificial intelligence has illuminated both its
vast potentials and its ethical challenges. As this paper has discussed, synthetic data ofers a crucial
advantage by reducing reliance on real data, thereby enhancing privacy and reducing the risks associated
with personal data breaches. However, the complexities of ensuring data accuracy, maintaining public
trust, and managing potential errors cannot be overlooked.</p>
      <p>The British perspective on synthetic data utilization in research advocates for a balanced approach,
emphasizing the necessity of stringent Data Protection measures alongside the benefits of synthetic data.
The UK’s regulatory framework and ethical guidelines serve as a beacon for other nations, promoting a
synthesis of utility and fidelity that respects both individual rights and the demands of technological
advancement.</p>
      <p>For synthetic data to truly benefit society, particularly in sensitive applications like healthcare,
developers and regulators must work in concert to forge policies that not only enhance data utility but
also prioritize transparency and accountability. Ensuring that synthetic data maintains its integrity
without compromising on ethical standards is essential for its acceptance and success.</p>
      <p>In conclusion, as synthetic data generation techniques continues to evolve, so too must our strategies
for its regulation and use. Only through a concerted efort to address these legal and ethical challenges
can we harness the full potential of synthetic data to propel AI development while safeguarding the
fundamental rights of individuals. Moving forward, the lessons learned from the British model should
inspire global standards that advocate for responsible and ethical synthetic data practices across all
sectors.
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