Journal of Computer and Communications, 2025, 13(5), 66-83
https://www.scirp.org/journal/jcc
ISSN Online: 2327-5227
ISSN Print: 2327-5219
DOI: 10.4236/jcc.2025.135005 May 26, 2025 66 Journal of Computer and Communications
Cross-Regional Analysis of Global AI
Healthcare Regulation
Pravin Ullagaddi
Plaster School of Business, University of the Cumberlands, Williamsburg, USA
Abstract
The rapid integration of artificial intelligence (AI) into healthcare has the po-
tential to revolutionize pharmaceutical and medical device industries, offering
unprecedented opportunities for innovation and improved patient care. How-
ever, these advancements necessitate robust regulatory frameworks to ensure
safety, efficacy, and ethical implementation. This paper critically examines key
regulatory guidelines issued by leading agencies worldwide, including the U.S.
Food and Drug Administration (FDA), European Medicines Agency (EMA),
China’s National Medical Products Administration (NMPA), and Singapore’s
Health Sciences Authority (HSA). Through comprehensive analysis of regula-
tory approaches across diverse healthcare systems and governance models, we
identify five critical convergent themes: risk-based frameworks, transparency
requirements, lifecycle management strategies, ethical considerations, and
global harmonization efforts. The research methodology combines systematic
review of regulatory documents with analysis of implementation cases, reveal-
ing significant variation in how jurisdictions balance innovation facilitation
with patient protection. Our findings highlight both the challenges and op-
portunities in developing internationally coherent AI governance, with par-
ticular focus on emerging models from East Asia and other regions that offer
alternative approaches to Western frameworks. By examining cross-regional
regulatory strategies, this work provides practical insights for policymakers,
industry leaders, and healthcare providers navigating the complex landscape
of AI regulation. We conclude that successful AI integration in healthcare de-
pends on adaptive regulatory models that address algorithmic bias, data pri-
vacy, and equitable access while fostering innovation through international
collaboration, regulatory sandboxes, and public-private partnerships.
Keywords
Artificial Intelligence, Machine Learning, Healthcare Regulation, FDA,
EMA, NMPA, Healthcare Policy, Global Governance
How to cite this paper: Ullagaddi, P. (2025)
Cross-Regional Analysis of Global AI Health-
care Regulation. Journal of Computer and
Communications, 13, 66-83.
https://doi.org/10.4236/jcc.2025.135005
Received: April 7, 2025
Accepted: May 23, 2025
Published: May 26, 2025
Copyright © 2025 by author(s) and
Scientific Research Publishing Inc.
This work is licensed under the Creative
Commons Attribution International
License (CC BY 4.0).
http://creativecommons.org/licenses/by/4.0/
Open Access