Cited by 112Artificial Intelligence in Healthcare and EducationHealthcare RegulationDigitalization, Law, and Regulation

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How the FDA Regulates AI

Harvey, H. Benjamin, Gowda, Vrushab·2020·Academic Radiology

DOI 10.1016/j.acra.2019.09.017

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Abstract

Recent years have seen digital technologies increasingly leveraged to multiply conventional imaging modalities' diagnostic power. Artificial intelligence (AI) is most prominent among these in the radiology space, touted as the "stethoscope of the 21st century" for its potential to revolutionize diagnostic precision, provider workflow, and healthcare expenditure. Partially owing to AI's unique characteristics, and partially due to its novelty, existing regulatory paradigms are not well suited to balancing patient safety with furthering the growth of this new sector. The current review examines the historic, current, and proposed regulatory treatment of AI-empowered medical devices by the US Food and Drug Administration (FDA). An innovative framework proposed by the FDA seeks to address these issues by looking to current good manufacturing practices (cGMP) and adopting a total product lifecycle (TPLC) approach. If brought into force, this may reduce the regulatory burden incumbent on developers, while holding them to rigorous quality standards, maximizing safety, and permitting the field to mature.

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Authors: Harvey, H. B., & Gowda, V.
Affiliations: Harvard University (US)
Corresponding author: Harvey, H. Benjamin
ORCID: Harvey, H. Benjamin
Gowda, Vrushab
Venue: Academic Radiology
Publisher: Elsevier BV
Published: 2020-01
Volume: 27
Issue: 1
Pages: 58-61
ISSN: 1076-6332 (ISSN-L)
DOI: 10.1016/j.acra.2019.09.017
OpenAlex: W2992147743
Cited by: 112
References: 12
Citations by year: 2026: 12 · 2025: 28 · 2024: 22 · 2023: 15 · 2022: 16 · 2021: 12 · 2020: 6
FWCI: 0.42
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Academic Radiology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
Social Sciences › Law › Digitalization, Law, and Regulation
Keywords: AI regulation, FDA, current good manufacturing practice, patient safety, medical device regulation, artificial intelligence in radiology, regulatory burden, quality standards
MeSH terms: Artificial Intelligence, Humans, Radiology, United States, United States Food and Drug Administration, Workflow, Patient Safety

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