Digital Health and Regulatory Affairs: A Comparative Analysis of Regulations in the USA, Europe, Canada, and Australia

Introduction: Digital health technologies, including mHealth, telemedicine, and AIpowered devices, are transforming global healthcare delivery. However, their rapid advancement introduces critical regulatory challenges, especially in areas like data privacy, cybersecurity, and the approval of AI-driven tools. Methods: This compilation includes an exhaustive literature search using several databases, including ScienceDirect, PubMed, Scopus, and Google Scholar, for the years 2019-2025 as well as the challenges faced before market authorization by different regulatory authorities of the U.S., Europe, Australia, and Canada. Results: It identifies that the varying approaches across different regions create difficulties in achieving consistent global regulations for digital health technologies. It also highlights the lack of clear approval processes and accountability for AI technologies. Discussion: Global regulatory harmonization remains limited, hindering the scalability of digital health tools. Clearer AI validation protocols and cybersecurity frameworks are urgently needed. Challenges related to data ownership, ethical AI use, and transparency persist. Conclusion: It emphasizes the need for global cooperation to develop consistent regulations and recommends ongoing post-market surveillance to ensure the safety and effectiveness of digital health tools while promoting innovation. The article also calls for an enhanced framework to address the challenges of data privacy and cybersecurity.