Processing of synthetic data in AI development for healthcare and the definition of personal data in EU law

The challenges and opportunities of mental health data sharing in the UK

Photo by Josh Riemer on Unsplash
 Introduction
 With the rapid advancements in neurotechnological machinery and improved analytical insights from machine learning in neuroscience, the availability of big brain data has increased tremendously. Neurological health research is done using digitized brain data.[1] There must be adequate data governance to secure the privacy of subjects participating in brain research and treatments. If not properly regulated, the research methods could lead to significant breaches of the subject’s autonomy and privacy. This paper will address the necessity for neuroprotection laws, which effectively govern the use of big brain data to ensure respect for patient privacy and autonomy.
 Background
 Artificial intelligence and machine learning can be integrated with neuroscience big brain data to drive research studies. This integrative technology allows patterns of electrical activity in neurons to be studied in detail.[2]Specifically, it uses a robotic system which can reason, plan, and exhibit biologically intelligent behavior. Machine learning is a method of computer programming where the code can adapt its behavior based on big brain data.[3] The big brain data is the collection of large amounts of information for the purpose of deciphering patterns through computer analysis using machine learning.[4] The information that these technologies provide is extensive enough to allow a researcher to read a patient’s mind. AI and machine learning technologies work by finding the underlying structure of brain data, which is then described by patterns known as latent factors, eventually resulting in an understanding of the brain’s temporal dynamics.[5]
 Through these technologies, researchers are able to decipher how the human brain computes its performances and thoughts. However, due to the extensive and complex nature of the data processed through AI and machine learning, researchers may gain access to personal information a patient may not wish to reveal. From a bioethical lens, tensions arise in the realm of patient autonomy. Patients are not able to control the transmission of data from their brains that is analyzed by researchers. Governing brain data through laws may enhance the extent of patient privacy in the case where brain data is being used through AI technologies.[6] A responsible approach to governing brain data would require a sophisticated legal structure.
 Analysis
 Impact on Patient Autonomy and Privacy 
 In research pertaining to big brain data, the consent forms do not fully cover the vast amounts of information that is collected. According to research, personal data has become the most sought out commodity to provide content to corporations and the web-based service industry. Unfortunately, data leaks that release private information frequently occur.[7] The storage of an individual’s data on technologies accessible on the internet during research studies makes it vulnerable to leaks, jeopardizing an individual’s privacy. These data leaks may cause the patient to be identified easily, as the degree of information provided by AI technologies are personalized and may be decoded through brain fingerprinting methods.[8]
 There has been an extensive growth in the development and use of AI. It is efficient in providing information to radiologists who diagnose various diseases including brain cancer and psychiatric disease, and AI assists in the delivery of telemedicine.[9] However, the ethical pitfall of reduced patient autonomy must be addressed by analyzing current AI technologies and creating more options for patient preference in how the data may be used. For instance, facial recognition technology[10] commonly used in health care produces more information than listed in common consent forms, threatening to undermine informed consent. Facial recognition software collects extensive data and may disclose more information than a person would prefer to provide despite being a useful tool for diagnosing medical and genetic conditions.[11] In addition, people may not be aware that their images are being used to generate more clinical data for other purposes. It is difficult to guarantee the data is anonymized. Consent requirements must include informing people about the complexity of the potential uses of the data; software developers should maximize patient privacy.[12] Furthermore, there is a “human element” in the use of AI technologies as medical providers control the use and the extent to which data is captured or accessed through the AI technologies.[13] People must understand the scope of the technology and have clear communication with the physician or health care provider about how the medical information will be used. 
 Existing Laws for Brain Data Governance 
 A strict system of defined legal responsibilities of medical providers will ensure a higher degree of patient privacy and autonomy when AI technologies and data from machine learning are used. Governing specific algorithmic data is crucial in safeguarding a patient’s privacy and developing a gold standard treatment protocol following the procurement of the information.[14] Certain AI technologies provide more data than others, and legal boundaries should be established to ensure strong performance, quality control, and scope for patient privacy and autonomy. For instance, currently AI technologies are being used in the realm of intensive neurological care. However, there is a significant level of patient uncertainty about how much control patients have over the data’s uses.[15] Calibrated legal and ethical standards will allow important brain data to be securely governed and monitored.
 Once brain signals are recorded and processed from one individual, the data may be merged with other data in Brain Computer Interface Technology (BCI).[16] To ensure a right and ability to retrieve personal data or pull it from the collection, specific regulations for varying types of data are needed.[17] The importance of consent and patient privacy must be considered through giving patients a transparent view of how brain data is governed.[18] The legal system must address discriminatory issues and risks to patients whose data is used in studies. Laws like the General Data Protection Regulation (GDPR) and the California Consumer Privacy Protection Act (CCPA) can serve as effective models to protect aggregated data. These laws govern consumer information and ensure the compliance when personal data is collected.[19] California voters recently approved expansion of the CCPA to health data. The Washington Privacy Act, which would have provided rights to access, change, and withdraw personal data, failed to pass. Other states should improve privacy as well,[20] although a federal bill would be preferable. Scientists at the Heidelberg Academy of Sciences argue for data security to be governed in a manner that balances patient privacy and autonomy with the commercial interests of researchers.[21] The balance could be achieved through privacy protections like those in the Washington Privacy Act. Although the Health Insurance Portability and Accountability Act (HIPAA) provides an overall framework to deter the likelihood of dangers to patient protection and privacy, more thorough laws are warranted to combat pervasive data transfer and analysis that technology has brought to the health care industry.[22] Breaches of patient privacy under current HIPAA regulations include releasing patient information to a reporter without their consent and sending HIV data to a patient’s employer without consent.[23] HIPAA does not cover information being shared with outside contractors who do not have an agreement with technology companies to keep patient data confidential. HIPAA regulations also do not always address blatant breaches on patient data confidentiality.[24] Patients must be provided with methods to monitor the data being analyzed to be able to view the extent of private information being generated via AI technologies. In health research, the medical purposes of better diagnosis, earlier detection of diseases, or prevention are ethical justifications for the use of the data if it was collected with permission, the person understood and approved the uses of the data, and the data was deidentified.
 A standard governance framework is required in providing the fairest system of care to patients who allow their brain data to be examined. Informed consent in the neuroscience field could reaffirm the privacy and autonomy of patients by ensuring that they understand the type of information collected. Laws also could protect data after a patient’s death. Malpractice in the scope of brain data could give people a cause of action critical in safeguarding patient’s rights. Data breach lawsuits will become common but generally do not cover deidentified data that becomes part of big data collection. A more synchronized approach to the collection and consent process will encourage an understanding of how big data is used to diagnose and treat patients. Some altruistic people may even be more likely to consent if they know the largescale data collection is helpful to treat and diagnose people. Others should have the ability to opt out of sharing neurological data, especially when there is not certainty surrounding deidentification.[25]
 Conclusion
 Artificial intelligence and machine learning technologies have the potential to aid in the diagnosis and treatment of people globally by extracting and aggregating brain data specific to individuals. However, the secure use of the data is necessary to build trust between care providers and patients, as well as in balancing the bioethical principles of beneficence and patient autonomy. We must ensure the highest quality of care to patients, while protecting their privacy, informed consent, and clinical trust. More sophis

Generation of Multimodal Longitudinal Synthetic Data By Artificial Intelligence to Improve Personalized Medicine in Hematology

On the Infringement upon Natural Personss Data Protection Rights by Natural Persons An EU-Centred Analysis

This chapter focuses on the rights and remedies that individual users of cloud computing services may enjoy under the EU's General Data Protection Regulation (GDPR). It begins by considering the concept of the individual as 'data subject', which is inextricably linked to the concept of 'personal data'. The term 'data subject' is not defined explicitly in the GDPR. Instead, it is referenced in parenthesis within the definition of personal data. The definition of personal data is purposefully broad so as to include the vast range of information from which an individual may be identified. The chapter then explores the rights afforded to data subjects, including the right to be informed; the rights of access, rectification, and erasure; the right to data portability; the right to object to processing; and the right not to be subject to automated decision making, including profiling. Finally, it looks at the remedies and compensation available to data subjects. One of the biggest challenges to data subjects knowing and being able to exercise their rights is a potential lack of transparency with regard to how and by whom their personal data are collected and further processed in the cloud.

The increasing availability of medical imaging data offers unprecedented opportunities for advancing artificial intelligence (AI)-driven healthcare. However, strict data protection regulations in the European Union (EU), especially the General Data Protection Regulation (GDPR), present significant challenges to data sharing and reuse. Synthetic data—artificially generated data that mimic the statistical properties of real data without revealing sensitive information—have emerged as a promising solution to bridge this gap. This perspective-style review examines the role of synthetic medical imaging data within the European Health Data Space (EHDS), a policy initiative aimed at enabling secure access to health data across the EU. While we briefly reference cross-cutting privacy-enhancing technologies and one non-imaging comparator to illuminate shared governance issues, our analysis and conclusions are scoped to imaging applications. We discuss the technical foundations and types of synthetic data, their potential to enhance reproducibility and innovation, and the complex ethical and legal concerns surrounding their use. Emphasising the need for a risk-based regulatory framework, we advocate for synthetic data governance that ensures utility, transparency, and accountability, especially when such data are generated using generative AI models. This work contributes to ongoing debates on how synthetic imaging data can support a privacy-preserving, data-driven healthcare ecosystem in Europe.

The sharing of personal health data is highly regulated due to privacy and security concerns. An alternative to sharing personal data is to share synthetic data, because ideally it should be impossible to reconstruct real personal data from synthetic data, which is called privacy. At the same time, the structure of the synthetic data should be as similar as possible to the structure of the real data to ensure that conclusions drawn from the synthetic data are also valid for the real data, which is called fidelity. Typically, there is a tradeoff between fidelity and privacy for synthetic health data. We study the fidelity and privacy of cancer data synthesized using generative machine learning approaches. To generate synthetic cancer data, we use variational autoencoders (VAEs), generative adversarial networks (GANs), and denoising diffusion probabilistic models (DDPMs). The tabular cancer registry data studied have nine categorical variables from breast cancer patients. We find that DDPMs generate synthetic cancer data with higher fidelity; that is, the structure of the synthetic data is more similar to the real cancer data than the data generated by VAEs and GANs. At the same time, synthetic cancer data from DDPMs pose a greater privacy risk because the data are more likely to reveal information from real patients than synthetic data from VAEs and GANs.

The development of artificial intelligence (AI) in healthcare is accelerating rapidly. Beyond the urge for technological optimization, public perceptions and preferences regarding the application of such technologies remain poorly understood. Risk and benefit perceptions of novel technologies are key drivers for successful implementation. Therefore, it is crucial to understand the factors that condition these perceptions. In this study, we draw on the risk perception and human-AI interaction literature to examine how explicit (i.e., deliberate) and implicit (i.e., automatic) comparative trust associations with AI versus physicians, and knowledge about AI, relate to likelihood perceptions of risks and benefits of AI in healthcare and preferences for the integration of AI in healthcare. We use survey data (N=378) to specify a path model. Results reveal that the path for implicit comparative trust associations on relative preferences for AI over physicians is only significant through risk, but not through benefit perceptions. This finding is reversed for AI knowledge. Explicit comparative trust associations relate to AI preference through risk and benefit perceptions. These findings indicate that risk perceptions of AI in healthcare might be driven more strongly by affect-laden factors than benefit perceptions, which in turn might depend more on reflective cognition. Implications of our findings and directions for future research are discussed considering the conceptualization of trust as heuristic and dual-process theories of judgment and decision-making. Regarding the design and implementation of AI-based healthcare technologies, our findings suggest that a holistic integration of public viewpoints is warranted.

Generative Artificial Intelligence (AI) is rapidly transforming the healthcare sector, offering novel approaches to medical imaging, drug discovery, personalized medicine, and data privacy through the generation of synthetic datasets. This paper explores the applications, challenges, and ethical considerations surrounding the use of generative AI in healthcare. Key applications of this technology include enhancing diagnostic capabilities by generating high-quality medical images, accelerating the drug discovery process by simulating chemical compounds, and tailoring treatment plans through personalized medicine. Generative AI's ability to create synthetic patient data also provides a promising solution for safeguarding patient privacy while advancing medical research. However, the integration of generative AI into healthcare is met with several challenges. These include data quality issues, which can compromise the accuracy and reliability of AI-generated outputs, and the black-box nature of many AI models, making it difficult for healthcare professionals to fully understand or trust the systems. Moreover, the technical limitations, such as high computational costs and the difficulty of integrating AI with existing healthcare infrastructure, pose additional barriers to widespread adoption. The ethical considerations of generative AI in healthcare are equally significant. Concerns over patient privacy and data security remain central, particularly when synthetic data is generated and used for research purposes. Furthermore, the potential for algorithmic bias to influence healthcare outcomes raises questions about fairness and equity in AI-driven decisions. Establishing clear lines of accountability and ensuring that AI systems comply with existing regulatory frameworks are essential for building trust and safeguarding patient well-being. Looking forward, the paper highlights the importance of developing explainable AI systems that offer greater transparency and integration with human decision-making processes. Future advancements in personalized medicine and drug discovery will rely on cross-disciplinary collaboration between AI researchers, healthcare professionals, and policymakers. Ultimately, the paper emphasizes that while generative AI holds tremendous potential for revolutionizing healthcare, its success will depend on addressing both the technical and ethical challenges it presents. Keywords: Generative Artificial Intelligence, Medical Imaging, Healthcare, Personalized Medicine, Synthetic Datasets, Diagnostic Capabilities, Patient Privacy, Explainable AI, Algorithmic Bias

This paper explores the potential applications of high-fidelity synthetic patient data in the context of healthcare research, including challenges and benefits. The paper starts by defining synthetic data, types of synthetic data and approaches to generating synthetic data. It then discusses the potential applications of synthetic data in addition to as a privacy enhancing technology and current debates around whether synthetic data should be considered personal data and,therefore, should be subjected to privacy controls to minimise reidentification risks. This will be followed by a discussion of privacy preservation approaches and privacy metrics that can be applied in the context of synthetic data. The paper includes a case study based on synthetic electronic healthcare record data from the Clinical Practice Research Datalink on how privacy concerns due to reidentification have been addressed in order to make this data available for research purposes. The authors conclude that synthetic data, particularly high-fidelity synthetic patient data, has the potential to add value over and above real data for public health and that it is possible to address privacy concerns to make synthetic data available via a combination of privacy measures applied during the synthetic data generation process and post-generation reidentification risk assessments as part of data protection impact assessments.

Use of neurosurgical data for clinical research and machine learning (ML) model development is often limited by data availability, sample sizes, and regulatory constraints. Synthetic data offer a potential solution to challenges associated with accessing, sharing, and using real-world data (RWD). The aim of this study was to evaluate the capability of generating synthetic neurosurgical data with a generative adversarial network and large language model (LLM) to augment RWD, perform secondary analyses in place of RWD, and train an ML model to predict postoperative outcomes. Synthetic data were generated with a conditional tabular generative adversarial network (CTGAN) and the LLM GPT-4o based on a real-world neurosurgical dataset of 140 older adults who underwent neurosurgical interventions. Each model was used to generate datasets at equivalent (n = 140) and amplified (n = 1000) sample sizes. Data fidelity was evaluated by comparing univariate and bivariate statistics to the RWD. Privacy evaluation involved measuring the uniqueness of generated synthetic records. Utility was assessed by: 1) reproducing and extending clinical analyses on predictors of Karnofsky Performance Status (KPS) deterioration at discharge and a prolonged postoperative intensive care unit (ICU) stay, and 2) training a binary ML classifier on amplified synthetic datasets to predict KPS deterioration on RWD. Both the CTGAN and GPT-4o generated complete, high-fidelity synthetic tabular datasets. GPT-4o matched or exceeded CTGAN across all measured fidelity, utility, and privacy metrics. All significant clinical predictors of KPS deterioration and prolonged ICU stay were retained in the GPT-4o-generated synthetic data, with some differences observed in effect sizes. Preoperative KPS was not preserved as a significant predictor in the CTGAN-generated data. The ML classifier trained on GPT-4o data outperformed the model trained on CTGAN data, achieving a higher F1 score (0.725 vs 0.688) for predicting KPS deterioration. This study demonstrated a promising ability to produce high-fidelity synthetic neurosurgical data using generative models. Synthetic neurosurgical data present a potential solution to critical limitations in data availability for neurosurgical research. Further investigation is necessary to enhance synthetic data utility for secondary analyses and ML model training, and to evaluate synthetic data generation methods across other datasets, including clinical trial data.

Background and Aims Synthetic data can be an effective supplement or alternative to real data for the training of machine learning models. Synthetic data may also be used to evaluate new tools, develop educational curricula, or remove undesirable biases in datasets. We aim to evaluate four synthetic data generation methods applied to hypertension randomized clinical trial data. Method The Systolic Blood Pressure Intervention Trial (SPRINT) trial showed that intensive BP control to SBP <120 mm Hg results in significant cardiovascular benefits in high-risk patients with hypertension compared with routine BP control to <140 mm Hg. The Synthetic Data Vault (SDV) is a Synthetic Data Generation ecosystem of libraries that allows users to easily generate new Synthetic Data that has the same format and statistical properties as the original dataset. SDV supports multiple types of data, including date-times, discrete-ordinal, categorical, and numerical. SPRINT data was pre-processed to create a single table of 140,000 patient visits with baseline variables (age, sex, race, aspirin use, estimated Glomerular Filtration Rate (eGFR)) and visit level variables (systolic and diastolic blood pressure, heart rate and total number of antihypertensive medications at end of visit). Using the SDV library for python, we used four generative models to create synthetic SPRINT data, 1. Gaussian copula model, 2. Conditional Tabular Generative adversarial network (CTGAN), 3. CopulaGan model, and 4. Tabular Variational Auto-encode (TVAE). We evaluated the results using the SDMetrics library which includes the shapes of the columns (marginal distributions), the pairwise trends between the columns (correlations), reproduce mathematical properties from your original data and new row synthesis. Finally, an overall quality score which represents an amalgamation of the marginal distribution and correlations was computed, where 0 indicates the lowest quality and 1 indicates the highest. Results Two hundred thousand synthetic patient visits were created for each method. The overall quality scores in order were 90.67% for Gaussian copula, 86.77% for TVAE, 81.03% for CTGAN’, and 79.7% for CopulaGAN. The column shape score which represents the marginal distribution was highest for Gaussian Copula (94.54%), followed by TVAE (88.44%), CTGAN (82.35%), and Copula GAN (80.27%). The column pair trend which corresponds to correlations was highest for Gaussian Copula (86.8%), followed by TAVE (85.1%), CTGAN (79.72%), and Copula GAN (79.12%). Conclusion Gaussian copula created the highest scoring synthetic SPRINT data based on the marginal distribution, correlations, and overall score. The Synthetic Data Vault is a feasible collection of methods for generation of synthetic clinical trial data for training future machine learning and AI models.

BackgroundThe integration of artificial intelligence (AI) holds substantial potential to alter diagnostics and treatment in health care settings. However, public attitudes toward AI, including trust and risk perception, are key to its ethical and effective adoption. Despite growing interest, empirical research on the factors shaping public support for AI in health care (particularly in large-scale, representative contexts) remains limited.ObjectiveThis study aimed to investigate public attitudes toward AI in patient health care, focusing on how AI attributes (autonomy, costs, reliability, and transparency) shape perceptions of support, risk, and personalized care. In addition, it examines the moderating role of sociodemographic characteristics (gender, age, educational level, migration background, and subjective health status) in these evaluations. Our study offers novel insights into the relative importance of AI system characteristics for public attitudes and acceptance.MethodsWe conducted a factorial vignette experiment with a probability-based survey of 3030 participants from Germany’s general population. Respondents were presented with hypothetical scenarios involving AI applications in diagnosis and treatment in a hospital setting. Linear regression models assessed the relative influence of AI attributes on the dependent variables (support, risk perception, and personalized care), with additional subgroup analyses to explore heterogeneity by sociodemographic characteristics.ResultsMean values between 4.2 and 4.4 on a 1-7 scale indicate a generally neutral to slightly negative stance toward AI integration in terms of general support, risk perception, and personalized care expectations, with responses spanning the full scale from strong support to strong opposition. Among the 4 dimensions, reliability emerges as the most influential factor (percentage of explained variance [EV] of up to 10.5%). Respondents expect AI to not only prevent errors but also exceed current reliability standards while strongly disapproving of nontraceable systems (transparency is another important factor, percentage of EV of up to 4%). Costs and autonomy play a comparatively minor role (percentage of EVs of up to 1.5% and 1.3%), with preferences favoring collaborative AI systems over autonomous ones, and higher costs generally leading to rejection. Heterogeneity analysis reveals limited sociodemographic differences, with education and migration background influencing attitudes toward transparency and autonomy, and gender differences primarily affecting cost-related perceptions. Overall, attitudes do not substantially differ between AI applications in diagnosis versus treatment.ConclusionsOur study fills a critical research gap by identifying the key factors that shape public trust and acceptance of AI in health care, particularly reliability, transparency, and patient-centered approaches. Our findings provide evidence-based recommendations for policy makers, health care providers, and AI developers to enhance trust and accountability, key concerns often overlooked in system development and real-world applications. The study highlights the need for targeted policy and educational initiatives to support the responsible integration of AI in patient care.

While synthetic data has the potential to address privacy concerns associated with real-world data in many scenarios — ranging from health applications to machine learning — organisations must proceed carefully to ensure they do not inadvertently violate the General Data Protection Regulation or other data protection laws. The boundaries between the processing of personal and anonymised data are sometimes overlooked, creating potential risks for individuals' rights and freedoms. This paper will start from a definition of synthetic data and, after reviewing some foreseeable use cases (also promoted by forthcoming sector legislations in the areas of artificial intelligence and data sharing), it will address the conditions set out in data protection laws (the EU General Data Protection Regulation in primis) in order to consider a set of data as properly anonymised, as well as the phases of synthetic data generation and use where personal data might still be processed, proposing some reflections towards genuine legal compliance.

The adoption of artificial intelligence (AI) in healthcare is rapidly expanding, transforming areas such as diagnostics, drug discovery, and patient monitoring. Despite these advances, public perceptions of AI in healthcare, particularly in Canada, remain underexplored. This study investigates the relationship between Canadians' knowledge, comfort, and trust in AI, focusing on key sociodemographic factors like age, gender, education, and income. Using data from the 2021 Canadian Digital Health Survey of 12,052 respondents, we employed ordinal logistic and multivariate polynomial regression analyses to uncover trends and disparities. Findings reveal that women and older adults consistently report lower levels of knowledge and comfort with AI, with middle-aged women expressing the most significant discomfort. Comfort levels are closely tied to concerns over data privacy, especially regarding the use of identifiable personal health data. Healthcare professionals exhibited heightened discomfort with AI, indicating potential issues with trust in AI’s reliability and ethical governance. Our results underscore that increasing knowledge alone does not necessarily lead to greater comfort with AI in healthcare. Addressing public concerns through robust data governance, transparency, and inclusive AI design is essential to fostering trust and successful integration of AI in healthcare systems.