Legal questions of AI-generated immunological products for infectious diseases

Artificial intelligence (AI) has potential to surpass human capabilities to reshape vaccine design. However, its integration raises legal, ethical, and intellectual property challenges. Transparency in AI-driven immunological products is crucial for regulatory approval and public trust. This article examines the "black-box" effect, liability concerns, and the need for human-interpretable reports summarizing the data processing and algorithm execution behind the AI-made decisions. This will ensure safety, accessibility, and regulatory compliance in the development of AI-generated vaccines and other immune therapeutics against infectious diseases.