Digital Therapeutics and Patient Autonomy: Proposals for Reconstructing the Informed Consent Process

This study explores the ethical challenges related to patient autonomy and informed consent that have emerged alongside the rise of digital therapeutics. Using Somzz, the first government-approved digital therapeutic device in South Korea, as a case study, the paper contends that in highly automated and opaque digital treatment environments, the conventional model of informed consent is insufficient for meaningfully safeguarding patient autonomy. To address this limitation, the study introduces the concept of processual consent, which highlights the necessity of iterative, context-aware communication throughout the therapeutic process. Furthermore, it emphasizes the critical role of explainable system design, user-centered interface development, and socio-educational support in enhancing patients’ digital and health literacy. These elements are essential for promoting ‘situated autonomy’ and ensuring the ethical legitimacy and trustworthiness of digital therapeutics.