Benefit-risk reporting for FDA-cleared AI−enabled medical devices
JAMA Health Forum
Published 2025-09-26 · Original archive entry · Explore research explainers
About The Study: This cross-sectional study suggests that despite increasing clearance of artificial intelligence (AI)/machine learning (ML) devices, standardized efficacy, safety, and risk assessment by the Food and Drug Administration (FDA) are lacking. Dedicated regulatory pathways and post-market surveillance of AI/ML safety events may address these challenges.
Corresponding Author: To contact the corresponding author, Ravi B. Parikh, MD, MPP, email ravi.bharat.parikh@emory.edu.
To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/
(doi:10.1001/jamahealthforum.2025.3351)
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.
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Embed this link to provide your readers free access to the full-text article This link will be live at the embargo time https://jamanetwork.com/journals/jama-health-forum/fullarticle/10.1001/jamahealthforum.2025.3351?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=092625
About JAMA Health Forum: JAMA Health Forum is an international, peer-reviewed, online, open access journal that addresses health policy and strategies affecting medicine, health and health care. The journal publishes original research, evidence-based reports and opinion about national and global health policy; innovative approaches to health care delivery; and health care economics, access, quality, safety, equity and reform. Its distribution will be solely digital and all content will be freely available for anyone to read.
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Corresponding Author: To contact the corresponding author, Ravi B. Parikh, MD, MPP, email ravi.bharat.parikh@emory.edu.
To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/
(doi:10.1001/jamahealthforum.2025.3351)
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.
# # #
Embed this link to provide your readers free access to the full-text article This link will be live at the embargo time https://jamanetwork.com/journals/jama-health-forum/fullarticle/10.1001/jamahealthforum.2025.3351?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=092625
About JAMA Health Forum: JAMA Health Forum is an international, peer-reviewed, online, open access journal that addresses health policy and strategies affecting medicine, health and health care. The journal publishes original research, evidence-based reports and opinion about national and global health policy; innovative approaches to health care delivery; and health care economics, access, quality, safety, equity and reform. Its distribution will be solely digital and all content will be freely available for anyone to read.
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