Regulatory Issues and Challenges to Artificial Intelligence Adoption
Abstract
Artificial intelligence technology promises to redefine the practice of radiology. However, it exists in a nascent phase and remains largely untested in the clinical space. This nature is both a cause and consequence of the uncertain legal-regulatory environment it enters. This discussion aims to shed light on these challenges, tracing the various pathways toward approval by the US Food and Drug Administration, the future of government oversight, privacy issues, ethical dilemmas, and practical considerations related to implementation in radiologist practice.
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A forward-looking approach to tracking and adhering to emerging regulations ensures that the integration of AI into medical education aligns with evolving legal frameworks.
“This forward-looking approach ensures that the integration of AI into medical education aligns with evolving legal frameworks, thereby safeguarding patient data, ensuring privacy, and upholding the ethical standards essential to responsible AI deployment in healthcare settings [53].”
From Twelve tips for addressing ethical concerns in the implementation of artificial intelligence in medical education (2024) · cites this paper as [53]
Alignment of AI integration in medical education with evolving legal frameworks safeguards patient data, ensures privacy, and upholds ethical standards essential to responsible AI deployment in healthcare settings.
“This forward-looking approach ensures that the integration of AI into medical education aligns with evolving legal frameworks, thereby safeguarding patient data, ensuring privacy, and upholding the ethical standards essential to responsible AI deployment in healthcare settings [53].”
From Twelve tips for addressing ethical concerns in the implementation of artificial intelligence in medical education (2024) · cites this paper as [53]
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- Authors
- Harvey, H. B., & Gowda, V.
- Affiliations
- Harvard University (US)
- Corresponding author
- Harvey, Harlan Benjamin
- Venue
- Radiologic Clinics of North America
- Publisher
- Elsevier BV
- Published
- 2021-11
- Volume
- 59
- Issue
- 6
- Pages
- 1075-1083
- ISSN
- 0033-8389 (ISSN-L)
- OpenAlex
- W3211326841
- Cited by
- 59
- References
- 26
- Citations by year
- 2026: 9 · 2025: 18 · 2024: 20 · 2023: 8 · 2022: 4
- FWCI
- 0.66
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Radiologic Clinics of North America (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Social Sciences › Law › Digitalization, Law, and Regulation
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- artificial intelligence adoption, radiology, regulatory challenges, government oversight, data privacy, AI ethics, clinical implementation, AI regulation
- MeSH terms
- Artificial Intelligence, Diagnostic Imaging, Humans, Image Interpretation, Computer-Assisted, Radiology, United States, United States Food and Drug Administration
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