Digital Therapeutics: regulatory Challenges for AI-based Healthcare Solutions

Abstract

Modern healthcare is changing as a result of the incorporation of Artificial Intelligence (AI) into digital treatments, which provide evidence-based, scalable and customized software based interventions. These AI-powered technologies have enormous promise for improving patient adherence, controlling chronic illnesses, and providing immediate clinical assistance. But because they are developing faster than current regulatory frameworks, there is a serious supervision, validation, and accountability vacuum. This review examines the intricate regulatory concerns surrounding AI-based digital therapies, such as those pertaining to data protection, real-world proof requirements, algorithm transparency, and software categorization. It also looks at how inconsistent regulatory requirements are throughout the world and how hard it is to stay up with AI systems that are flexible and always learning from fresh data.

This article emphasizes the essential need for a unified and flexible regulatory environment that strikes a balance between innovation, patient safety and ethical responsibility through a multidisciplinary perspective. The information offered is intended to help developers, regulators and healthcare stakeholders create governance frameworks that can facilitate the safe and efficient application of AI in therapeutic contexts.