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2000
Volume 11, Issue 1
  • ISSN: 2667-3371
  • E-ISSN: 2667-338X

Abstract

Introduction

Digital health technologies, including mHealth, telemedicine, and AI-powered 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.

© 2025 Bentham Science Publishers
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2025-09-15
2026-04-13

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Digital Health and Regulatory Affairs: A Comparative Analysis of Regulations in the USA, Europe, Canada, and Australia
Appl. Drug Resea., Clin. Trials and Regu. Affa. 11, E26673371404752 (2025); https://doi.org/10.2174/0126673371404752250827231906
/content/journals/adctra/10.2174/0126673371404752250827231906
/content/journals/adctra/10.2174/0126673371404752250827231906
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  • Article Type:     Review Article
Keyword(s): AI regulations; cybersecurity; data privacy; digital health; mHealth; post-marketing surveillance

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