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Artificial intelligence (AI) is rapidly transforming healthcare, with the potential to revolutionize patient outcomes, particularly in areas such as early cancer detection and personalized medicine. Within the ONCOSCREEN project, we aim to provide comprehensive solutions for risk-stratified cancer screening programs for citizens, integrated diagnostic decision support tools for clinicians, and intelligent monitoring tools for policymakers. By leveraging AI-powered technologies, ONCOSCREEN enhances the accuracy of cancer screening, offering significant benefits in diagnosis and patient care. However, this integration of AI in healthcare also raises critical challenges regarding fundamental rights, including privacy, non-discrimination, and autonomy. As we harness these technologies, it is essential to remain vigilant about their ethical and legal implications.

Data Privacy and Protection

AI systems rely on vast datasets, often containing sensitive personal and health-related information. For ONCOSCREEN, these datasets are instrumental in developing advanced colorectal cancer screening tools, necessitating strict adherence to privacy laws such as the General Data Protection Regulation (GDPR). The GDPR mandates that personal data—particularly sensitive health information—be processed transparently and securely, ensuring that individuals’ privacy is upheld.

Balancing the need for extensive data with the responsibility to protect patient information is a key challenge. Patients must give explicit consent for the use of their data and understand how it will be processed, stored, and shared. Given the complexity of AI algorithms, transparency is critical to overcoming the “black-box phenomenon,” where the decision-making process becomes opaque. To maintain trust, we focus on data minimization—collecting only the information necessary for AI functionality—while applying encryption and anonymization techniques to safeguard patient privacy.

Non-Discrimination and Equality

A major concern in AI-driven healthcare is the risk of bias in algorithms. AI systems learn from historical data, and if that data reflects existing inequalities in healthcare, AI recommendations can perpetuate or even worsen these disparities. In cancer screening, this could result in demographic groups such as women, ethnic minorities, or lower socioeconomic populations receiving less accurate diagnoses.

ONCOSCREEN is committed to addressing algorithmic bias to ensure fairness and equality in healthcare. We rigorously evaluate the datasets used to train our AI models, ensuring they are diverse and representative of the populations they serve. Our goal is to develop AI systems that provide accurate, personalized diagnostics for all patients, regardless of their background. This commitment aligns with the EU’s Charter of Fundamental Rights, which guarantees non-discrimination and equal treatment.

Autonomy and Informed Consent

AI’s growing role in healthcare raises important questions about patient autonomy and informed consent. While AI tools can enhance diagnostic accuracy and inform treatment plans, the final responsibility for patient care rests with human professionals. Human oversight is essential to ensure that AI recommendations are critically assessed, not followed blindly.

Patients must be fully informed about the role of AI in their diagnosis or treatment, understanding both its capabilities and limitations. This transparency allows patients to ask questions and make informed decisions about their care, including the right to consent to or refuse certain AI-assisted treatments. Clear communication about AI’s involvement in healthcare is essential to upholding patient autonomy.

ONCOSCREEN’s Ethical Commitment

As a Horizon Europe project, ONCOSCREEN is committed to leveraging AI in ways that respect and uphold fundamental rights. By incorporating privacy-by-design principles from the outset, we ensure that patient data is treated with the highest levels of care, and that our algorithms are transparent, unbiased, and always subject to human oversight. Our objective is to advance early detection of colorectal cancer while ensuring equitable access to AI-driven healthcare benefits.

In line with trustworthy AI principles, as outlined by the European Union and other international bodies, ONCOSCREEN emphasizes transparency, accountability, fairness, and safety in our AI systems. These principles are embedded into the design, development, and deployment of our technologies to align with ethical and legal standards, ultimately fostering trust in AI-powered healthcare.

Additionally, ONCOSCREEN adheres to the requirements of the AI Act, which regulates high-risk AI applications, including healthcare. This framework emphasizes risk management, data governance, human oversight, and transparency. To comply with these standards, ONCOSCREEN implements comprehensive risk assessments, bias mitigation strategies, and continuous monitoring, ensuring that our AI systems remain ethical, secure, and reliable.

Conclusion

AI holds transformative potential in healthcare, but its implementation must be thoughtful to protect fundamental rights. ONCOSCREEN is committed to fostering trust in AI-driven healthcare by prioritizing privacy, promoting equality, and safeguarding patient autonomy. By addressing ethical challenges head-on and adhering to regulatory frameworks such as the AI Act, we aim to deliver innovations that improve healthcare while ensuring that the benefits of AI are shared fairly and responsibly.