In this paper, the role of artificial intelligence (AI) in healthcare is explored, emphasizing possible contributions to health inequities and digital ageism. The focus, specifically, considers how AI-driven medical devices can unintentionally reinforce biases, particularly affecting marginalized populations and older adults, within the framework of EU regulations.  The paper also discusses potential solutions through regulatory reforms to promote the development and use of medical technologies that are more inclusive and equitable.

The following topics are highlighted and explored: 

• AI and health inequity

AI systems in healthcare often reinforce existing disparities due to biased datasets that under-represent vulnerable groups. This chapter examines how these biases lead to unequal care and stresses the importance of diverse and inclusive data to promote fairer healthcare practices.

• The rise of digital ageism

Older adults are frequently overlooked in datasets used to develop AI-driven medical devices, resulting in tools poorly suited to their needs. This chapter underscores the importance of designing inclusive AI systems that address the unique health challenges of aging populations, helping to combat digital ageism.

• Mitigating biases through the EU regulatory framework

The EU's MDR and IVDR frameworks are highlighted as effective tools for ensuring fairness and transparency in AI medical devices. This chapter focuses on how these regulations enforce rigorous testing on diverse populations and continuous monitoring, fostering equity in healthcare delivery.

• Policy recommendations and conclusion

To address biases, the paper suggests implementing fairness audits, continuous performance evaluations, and collaborative efforts among stakeholders. It concludes with a call for proactive regulations to ensure that AI improves healthcare for all demographics 

Conclusion

The  paper presents a strong argument for the importance of regulatory frameworks in mitigating biases in AI-driven medical devices. It emphasizes that inclusivity in AI design and testing is essential to prevent issues such as digital ageism and health inequities. By adapting and expanding upon the EU’s existing regulatory structures, the author suggests a global blueprint for ensuring AI benefits are distributed fairly. These strategies aim to reduce the potential harms of AI, thus contributing to a more just and accessible healthcare system.