Tag: EU Charter of Fundamental Rights

  • Beyond Ethics: How Europe Is Regulating AI in Healthcare

    Beyond Ethics: How Europe Is Regulating AI in Healthcare

    Knowing that AI can be biased is one thing. Knowing what to do about it, legally and ethically, is another. 

    Medicine’s ethical foundations, extended to AI

    Medicine has long been associated with high ethical standards, from the Hippocratic Oath to the Declarations of Geneva and Helsinki. Unfortunately, the history of medicine includes deeply troubling chapters, from eugenics, forced sterilisation of indigenous and marginalised populations, to non-consensual experimentation on people with disabilities. These historical failures are directly relevant today because the structural injustices behind them shaped decades of medical data collection, and their legacy is exactly what today’s AI systems risk inheriting when trained on that same data.

    Biomedical ethics is built around four core ethical principles: autonomy (respecting a person’s right to make their own decisions), non-maleficence (avoiding harm), beneficence (actively promoting wellbeing), and justice (distributing benefits and risks fairly, especially given known disparities based on race, gender, and social status) (Beauchamp & Childress, 2019).

    As AI entered clinical practice, ethicists added a fifth principle specifically for these technologies: explicability, the idea that the reasoning behind an AI system’s decisions must be understandable and open to scrutiny, not simply accepted at face value (Floridi et al., 2018). 

    The EU’s legal response

    The European Union has built a multi-layered legal framework specifically to address these risks. At its centre is the AI Act, which classifies many healthcare applications, including diagnostic tools and clinical decision-support systems, as “high-risk.” This means they’re subject to strict requirements: providers must actively identify and mitigate risks of discriminatory outcomes, ensure meaningful human oversight, and maintain accuracy and transparency throughout the system’s lifecycle (EU AI Act, 2024).

    Hospitals that deploy these systems have specific legal obligations too, including using AI in line with provider instructions, assigning competent human oversight, maintaining logs of system operation, and reporting serious incidents, particularly where there’s a risk of unequal outcomes across patient groups.

    The AI Act doesn’t stand alone. It works alongside the Medical Device Regulation (MDR; European Union, 2017a) and In Vitro Diagnostic Regulation (IVDR; European Union, 2017b), which govern the safety of medical technologies, the GDPR (European Union, 2016), which protects the sensitive health data these systems rely on, and the emerging European Health Data Space (EHDS; European Union, 2025), designed to enable more representative datasets for future AI development. Together, they form a legal ecosystem, all ultimately grounded in the EU Charter of Fundamental Rights (2009), particularly its guarantees of non-discrimination, equality, and the right to healthcare.

    All these policies translate into real responsibilities for hospitals and healthcare professionals, from understanding a tool’s limitations and knowing when to override its recommendations, to being transparent with patients about when and how these systems are used in their care.

    Beyond raising awareness, the AEQUITAS project has developed a practical AI Regulatory Model that translates these legal and ethical principles into concrete steps hospitals and healthcare professionals can actually apply, turning complex EU legislation into something usable in everyday clinical practice.

    References:

    Beauchamp, T. L., & Childress, J. F. (2019). Principles of biomedical ethics (8th ed).

    European Commission, Timeline for Implementation of the EU AI Act, Brussels: European Commission, 2024.

    European Union. (2009). Charter of Fundamental Rights of the European Union. Official Journal of the European Union, C 303/1. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:12012P/TXT

    European Union, Regulation (EU) 2016/679 on General Data Protection Regulation (GDPR), Brussels: EU, 2016.

    European Union, Regulation (EU) 2017/745 on Medical Devices (MDR), Official Journal of the European Union, L117, Brussels: European Union, 2017.

    European Union, Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), Official Journal of the European Union, L117, Brussels: European Union, 2017.

    European Union, Regulation (EU) 2025/327 on the European Health Data Space (EHDS), Brussels: European Union, 2025.

    Floridi, L., Cowls, J., Beltrametti, M., Chatila, R., Chazerand, P., Dignum, V., Luetge, C., Madelin, R., Pagallo, U., Rossi, F., Schafer, B., Valcke, P., & Vayena, E. (2018). AI4People—An Ethical Framework for a Good AI Society: Opportunities, Risks, Principles, and Recommendations. Minds and Machines, 28(4), 689–707. https://doi.org/10.1007/s11023-018-9482-5

  • When “Neutral” Data Isn’t: Gender and Racial Bias in Biomedical AI

    When “Neutral” Data Isn’t: Gender and Racial Bias in Biomedical AI

    Bias in AI isn’t abstract. It shows up in real diagnoses, real treatment decisions, and real patients, particularly those who already face multiple layers of disadvantage. Discrimination in AI is an intersectional issue, overlapping with age, gender, race, sexual orientation, and health status, among other dimensions of identity. The patients most at risk of being harmed by biased AI tools are often those who already face the most barriers to quality care.

    Decades of biased medical data

    The biases we see in AI didn’t come from nowhere. They’re a direct consequence of medical data collected over decades, data shaped by systemic discrimination and structural inequalities in healthcare research and practice (Cirillo et al., 2020; Cross et al., 2024).

    For much of medical history, clinical and experimental studies focused predominantly on male participants. This is what is known as the gender health gap. In 2020, only 5% of global health research funding went to women’s health research. This was split into 4% for women’s cancers and 1% for all other women-specific health conditions, with 25% of that further limited to fertility research (Nature Reviews Bioengineering, 2024). 

    It’s worth noting this isn’t a one-way problem: in some areas, such as depression, men are underrepresented in clinical data, largely because they’re less likely to seek care, report symptoms, or receive a diagnosis (Smith et al., 2018).

    Racial bias is equally well documented

    Racial bias in medicine is also extensively documented, particularly in the United States where research shows that, for instance, Black patients and other minority groups receive fewer medical procedures, lower rates of surgical intervention, and fewer referrals to specialists than white patients, regardless of clinical need (Bowser, 2001; Williams & Wyatt, 2015). When AI systems are trained on data that reflects decades of existing inequalities in healthcare access and treatment, they risk encoding and perpetuating those inequalities at a much larger scale. While much of the evidence comes from the US, the structural conditions producing racial bias, including socioeconomic inequalities, barriers to access and underrepresentation in research, are present across Europe too.

    LGBTQIA+ patients face their own layer of risk

    It is also important to recognise the specific situation of LGBTQIA+ individuals, who experience discrimination in healthcare and are subject to stereotypes that affect the care they receive. These social and cultural factors perpetuate discrimination and have a measurable impact on health and healthcare. Research has shown that 16% of LGBTQIA+ individuals report discrimination in healthcare encounters, and 18% avoid seeking care altogether due to fear of mistreatment (Chang et al., 2025). Another large-scale study found that in emergency department scenarios, AI recommendations for LGBTQIA+ patients included mental health interventions six to seven times more often than was clinically appropriate (Chang et al., 2025).

    How this plays out in three key areas

    In cardiovascular care, women’s symptoms often differ from the “classic” presentation described in medical textbooks, itself largely based on male patient data (Fatunde et al., 2025). As a result, women are offered fewer diagnostic tests, less medication, and fewer specialist referrals (Al Hamid et al., 2024). Racial bias compounds the problem: pulse oximeters, devices routinely used to measure blood oxygen saturation, have been shown to produce less accurate readings for patients with darker skin tones (Sjoding et al., 2020), a bias that then feeds directly into AI-based triage systems.

    In diabetes care, racial bias is extensively documented. Studies have shown that African American patients present systematically higher A1c values than white patients with the same average blood glucose (Karter et al., 2023). If an AI system uses A1c as a proxy for glycaemic control without accounting for this, it risks producing incorrect diagnoses for Black patients.

    In depression, both gender and racial bias carry significant weight, especially in tools using natural language processing for screening. Men and women tend to express psychological distress differently (Pennebaker et al., 2003), so a system trained predominantly on one gender’s language patterns may screen inaccurately for the other. Most mental health AI tools also still operate on binary gender assumptions, excluding non-binary, transgender, and gender non-conforming individuals from both the data and the populations these tools are meant to serve (Hafner et al., 2024).

    Why this matters

    These biases translate into delayed diagnoses, inappropriate treatments, and unequal care, every day, for real patients. Understanding these patterns is exactly what equips healthcare professionals to ask better questions, challenge assumptions, and advocate for the patients most at risk, which is precisely what the AEQUITAS training is designed to do.

    References:

    Chang, C.T., Srivathsa N., Bou-Khalil, C., Swaminathan, A., Lunn, M.R., Mishra, K., Koyejo, S,. Daneshjou, R. (2025). Evaluating anti-LGBTQIA+ medical bias in large language models. PLOS Digit Health 4(9): e0001001. https://doi.org/10.1371/journal.pdig.0001001

    Cirillo, D., Catuara-Solarz, S., Morey, C., Guney, E., Subirats, L., Mellino, S., Gigante, A.A., Valencia, A., Rementeria, M.J., Chadha, A.S., & Mavridis, N. (2020). Sex and gender differences and biases in artificial intelligence for biomedicine and healthcare. npj Digit. Med. 3(81). https://doi.org/10.1038/s41746-020-0288-5

    Cross, J. L., Choma, M. A., & Onofrey, J. A. (2024). Bias in medical AI: Implications for clinical decision-making. PLOS Digital Health, 3(11), e0000651. https://doi.org/10.1371/journal.pdig.0000651

    Funding research on women’s health. (2024). Nature Reviews Bioengineering, 2, 797–798. https://doi.org/10.1038/s44222-024-00253-7

    Hafner, F.S., Valdivia, A., Rocher, L. 2025. Gender Trouble in Language Models: An Empirical Audit Guided by Gender Performativity Theory. FAccT ’25: Proceedings of the 2025 ACM Conference on Fairness, Accountability, and Transparency, 1677–1695. https://doi.org/10.1145/3715275.3732112

    Karter, A. J., Parker, M. M., Moffet, H. H., & Gilliam, L. K. (2023). Racial and Ethnic Differences in the Association Between Mean Glucose and Hemoglobin A1c. Diabetes Technology & Therapeutics, 25(10), 697–704. https://doi.org/10.1089/dia.2023.0153

    Pennebaker, J. W., Mehl, M. R., & Niederhoffer, K. G. (2003). Psychological Aspects of Natural Language Use: Our Words, Our Selves. Annual Review of Psychology, 54(1), 547–577. https://doi.org/10.1146/annurev.psych.54.101601.145041

    Sjoding, M. W., Dickson, R. P., Iwashyna, T. J., Gay, S. E., & Valley, T. S. (2020). Racial Bias in Pulse Oximetry Measurement. New England Journal of Medicine, 383(25), 2477–2478. https://doi.org/10.1056/NEJMc2029240

    Smith, D.T., Mouzon, D.M., & Elliott, M. (2018). Reviewing the assumptions about men’s mental health: An exploration of the gender binary. American Journal of Men’s Health, 12(1), 78–89. https://doi.org/10.1177/1557988316630953

    Bowser, R. (2001). Racial bias in medical treatment. Dick. L. Rev., 105(3), 365.

    Williams, D. R., & Wyatt, R. (2015). Racial Bias in Health Care and Health: Challenges and Opportunities. JAMA, 314(6), 555. https://doi.org/10.1001/jama.2015.9260

  • The Hidden Ways AI Can Discriminate

    The Hidden Ways AI Can Discriminate

    When we talk about bias in AI, we are referring to “computer systems that systematically and unfairly discriminate against certain individuals or groups in favour of others” (Friedman & Nissenbaum, 1996). This is not about occasional errors, but about consistent, predictable patterns of unfair outcomes. Furthermore, biases in AI systems are complex, as they can enter the system at almost any stage, from the data it’s trained on to the way it’s ultimately used in a hospital setting. Recognising where bias originates, and how different types can reinforce each other, is the first step towards addressing it.

    Three broad roots of bias

    Researchers have identified three broad categories of bias that apply to all computer systems. The first is pre-existing bias, which comes from existing inequalities in society that get absorbed into the system, sometimes without anyone realising it (Friedman & Nissenbaum, 1996). The second is technical bias, which arises from the practical compromises made when translating complex human realities into clean computational form. And the third is emergent bias, which appears only after a system is deployed, as the world around it changes in ways the original design never anticipated.

    Bias in the AI pipeline

    These three categories give us a useful starting point. But for AI and machine learning specifically, researchers have identified seven more precise bias types that can affect these systems throughout their development and use (Suresh & Guttag, 2021):

    Historical bias reflects prejudices and stereotypes already present in training data, even if the data is technically accurate. A 1990 study found that after coronary bypass surgery, male patients received pain medication significantly more often than female patients, who were instead given sedatives more frequently (Calderone, 1990). An AI trained on data like this would learn to replicate that same pattern, perpetuating the very inequality it inherited.

    Representation bias happens when certain groups are underrepresented in training data. An AI trained mostly on data from one demographic will simply perform worse for everyone else. A well-known example is skin cancer detection tools that are significantly less accurate for patients with darker skin tones because the training datasets contained predominantly images from fair-skinned individuals (Guo et al., 2021).

    Measurement bias creeps in when the way something is measured isn’t equally accurate or fair across groups. One striking case involved an algorithm that used healthcare costs as a proxy for how sick someone actually was, and that ended up disadvantaging Black patients, who, facing disproportionate levels of poverty, tended to spend less on healthcare than equally sick white patients (Obermeyer et al., 2019).

    Aggregation bias occurs when a single, one-size-fits-all model is applied to genuinely diverse populations, ignoring the fact that the same data point can mean very different things depending on a person’s background.

    Learning bias emerges from technical decisions made while building the model itself, choices that can amplify disparities already present in the data, sometimes without the developers being aware. Research has shown, for instance, that differential privacy, a technique meant to protect patient confidentiality, can end up reducing a model’s accuracy for underrepresented groups even further (Bagdasaryan & Shmatikov, 2019).

    Evaluation bias happens when the datasets used to test and benchmark the model don’t reflect the real population it will actually serve, meaning a system can look accurate on paper while quietly failing specific groups of patients in practice.

    Finally, deployment bias arises when a tool is used in a context very different from the one it was designed and tested for, undermining its reliability in ways that are easy to miss.

    Why this matters for patients

    Understanding where bias comes from is the first step to catching it, and to making sure the AI tools shaping modern medicine work fairly for everyone, not just the patients who happen to be well represented in the data.

    This is exactly the kind of practical, structured understanding the AEQUITAS training equips healthcare professionals with, helping them recognise these patterns before they translate into real harm for real patients.

    References:

    Bagdasaryan, E., & Shmatikov, V. (2019). Differential Privacy Has Disparate Impact on Model Accuracy (arXiv:1905.12101). arXiv. https://doi.org/10.48550/arXiv.1905.12101

    Calderone, K. L. (1990). The influence of gender on the frequency of pain and sedative medication administered to postoperative patients. Sex Roles, 23(11), 713–725. https://doi.org/10.1007/BF00289259

    Friedman, B., & Nissenbaum, H. (1996). Bias in computer systems. ACM Transactions on Information Systems, 14(3), 330–347. https://doi.org/10.1145/230538.230561

    Guo, L. N., Lee, M. S., Kassamali, B., Mita, C., & Nambudiri, V. E. (2021). Bias in, bias out: Underreporting and underrepresentation of diverse skin types in machine learning research for skin cancer detection-A scoping review. Journal of the American Academy of Dermatology, S0190-9622(21)02086-7. https://doi.org/10.1016/j.jaad.2021.06.884

    Obermeyer, Z., Powers, B., Vogeli, C., & Mullainathan, S. (2019). Dissecting racial bias in an algorithm used to manage the health of populations. Science, 366(6464), 447–453. https://doi.org/10.1126/science.aax2342

    Suresh, H., & Guttag, J. (2021). A Framework for Understanding Sources of Harm throughout the Machine Learning Life Cycle. Equity and Access in Algorithms, Mechanisms, and Optimization, EAAMO ’21, 1–9. https://doi.org/10.1145/3465416.3483305

  • Seniors Neuropsychological Disorders Patients & EU Fundamental Rights

    Seniors Neuropsychological Disorders Patients & EU Fundamental Rights

    Proposal:  Safeguarding dementia & other neuropsychological disorders patients’ and caregivers’ rights through strategic litigation in Europe

    Proposed Implementation: 2026 to 2029

    Call: CERV-2025-CHAR-LITI – Call for proposals to promote civil society organisations’ awareness of, capacity building and implementation of the EU Charter of Fundamental Rights

    Proposed Budget: 421 359,58€

    Keywords: dementia, Strategic litigation, EU Charter, rights, neuropsychological disorders, seniors

    Objective: Seniors with dementia or other neuropsychological disorders face some of the highest risks of rights violations in the EU, ranging from unequal access to services and healthcare, to neglect, abuse, and discrimination. Despite the protection offered by the EU Charter of fundamental rights, their rights often remain unrecognized or unenforced. Caregivers, who can play a crucial role in safeguarding these rights, frequently lack adequate knowledge and support to act as advocates. Most civil society organizations working with them have not yet used the potential of strategic litigation, thus missing an important opportunity to defend and promote their rights.

    The project addresses this gap by empowering seniors with dementia or other neuropsychological disorders and their caregivers, while strengthening the capacity of civil society organizations, human rights defenders, legal professionals & practitioners, Ombuds Institutions, equality bodies & national human rights institutions to use the EU Charter for advocacy and strategic litigation.

    The project’s impact will be threefold: 

    -Empowerment and dignity for seniors with dementia or other neuropsychological disorders, who will gain accessible tools (home toolkit) and dedicated support (rights advocators) to make their voices heard.

    -Strengthened advocacy and protection by caregivers, volunteers, and professionals, who will act as “rights advocators” and ensure continuity beyond the project’s lifespan.

    -Systemic change through capacity building of organizations, institutions & professionals across Europe, making rights enforcement a shared and ongoing responsibility.

    By combining empowerment of individuals with structural capacity-building, the project will help transform awareness into action and action into systemic change, ensuring that the rights of seniors with dementia or other neuropsychological disorders are not only recognized in principle but fully enforced in practice across the EU.

    Partners:

    • Challedu Astiki Mi Kerdoskopiki Etaireia
    • Health Citizens – European Institute
    • Koinofeles Somateio Arogis Kai Frontidas Ilikiomeel 
    • Kentro Evropaikou Syntagmatikou Dikaio Idryma 
    • Erevnitiko Idrima
    • Cooperativa Sociale Cooss Marche Onlus Societa
    • Komiteen for Sundhedsoplysning
  • Neuropsychological Disorders, Seniors and Fundamental Rights

    Neuropsychological Disorders, Seniors and Fundamental Rights

    Proposal: Strategic Litigation to Address Seniors Rights in European Union

    Proposed Implementation:  2025 to 2027

    Call:  CERV-2024-CHAR-LITI – Promote civil society organisations’ awareness of, capacity building and implementation of the EU Charter of Fundamental Rights

    Proposed Budget: 508 057,40€

    Keywords: Strategic Litigation, Seniors, Neuropsychological disorders, Dementia, civil society organizations, capacity building, legal professionals and practitioners, human rights defenders, EU Charter

    Objective: the project aims to promote Strategic Litigation actions and enforcement of the EU Charter of Fundamental Rights to address breaches of the rights of Seniors and especially those with neuropsychological disorders. The project intends to form a community of practice to share knowledge and improve the multistakeholder cooperation and exchange of good practices among civil society organizations , human rights defenders, legal professionals and practitioners, Ombuds Institutions, equality bodies and independent human rights bodies.

    The project also wants to develop tools on how to use EU Charter for strategic litigation of Seniors, developing the organizations ability to develop a litigation strategy and communicate and advocate on fundamental rights of Seniors under the Charter. As well as conducting research on case studies, and creating an advocacy campaign with short videos and podcasts on social media workshops increasing the awareness and knowledge of the key target groups and general public of seniors’ rights under EU law.

    Partners:

    • Challedu
    • Health Citizens – European Institute
    • Corporation for Succor and Care of Elderly and Disabled
    • Kentro Evropaikou Syntagmatikou Dikaio Idryma 
    • Erevnitiko Idrima
    • Cooperativa Sociale Cooss Marche Onlus Societa