Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan.

Abstract

Digital therapeutics (DTx) and other forms of therapeutic artificial intelligence (AI) are becoming increasingly embedded in healthcare systems and everyday health practices. Unlike earlier forms of medical AI, which mainly support diagnostic decision-making, therapeutic AI systems interact continuously with patients and may influence health-related behaviour over time. These characteristics raise ethical, legal, and social implications (ELSI) that extend beyond conventional concerns about safet