Integrating participatory research and literature review to identify social and ethical requirements for responsible AI in heart failure treatment

The rapid advancement of Artificial Intelligence (AI) in healthcare raises significant social and ethical concerns, particularly in cardiovascular care, the leading cause of death worldwide. Addressing these challenges requires a multidisciplinary, multi-stakeholder approach to ensure the responsible development and implementation of AI-driven solutions. First, a literature review examined how key ethical principles – namely, autonomy, confidentiality, data privacy, and equal treatment – are integrated into AI applications for heart failure care. These findings informed an online workshop with patient representatives, clinicians, and experts on ethical, legal, and social issues to discuss ethical concerns and practical implications. A team of requirements engineers and digital health experts synthesized insights from the literature review and workshop, specifying an initial set of requirements. Following multiple iterations with a multidisciplinary review team, the final set of 25 requirements was established. These were translated into software or system specifications where applicable or used to define guidelines for real-world implementation. This study provides a structured approach to embedding ethical and social considerations into AI-driven healthcare solutions. Its methods and key requirements are transferable to other AI applications in public health, promoting responsible and equitable adoption.