디지털 치료기기(디지털 치료제) 규제의 이론적 기초와 적용 — 메타규제(Meta-Regulation)의 검토 —

In our society, the rapid aging of the population and the accompanying increase in chronic diseases are becoming significant social issues. Digital therapeutics(DTx), a product of advanced ICT and digital technology, represent a new and innovative therapeutic approach distinct from traditional treatments. They can serve as promising options to address the social issues mentioned above. DTx, as medical devices related to public health, are subject to strict regulation, yet due to their inherent characteristics, they are also not suitable for traditional normative regulation. Therefore, in response to changes in regulatory environments, it is necessary to consider the application of meta-regulation as a newly emerging regulatory system or approach. Meta-regulation can be described as a process-oriented cooperative regulation, distinct from the traditional outcome-oriented normative regulation centered around control. It shares similarities with self-regulation in that it delegates a significant portion of discretion regarding regulatory methods to the regulated entities. However, it is distinct from self-regulation in that regulatory authorities still maintain control, directing regulated entities to solve problems themselves and encouraging or obligating them to create rules. In this respect, meta-regulation can be assessed as enforced self-regulation. Given that the DTx industry represents a leading technology-driven emerging sector of modern society, regulated entities need to take on a certain level of regulatory leadership and contribute to the establishment of a regulatory framework. In this regard, the core principles, best practices, and code of ethics presented by the Digital Therapeutics Alliance(DTA) could serve as valuable references for regulated entities in establishing regulatory frameworks.