Benefit-Risk Reporting for FDA-Cleared Artificial Intelligence−Enabled Medical Devices
This cross-sectional study suggests that despite increasing clearance of AI/ML devices, standardized efficacy, safety, and risk assessment by the FDA are lacking. Dedicated regulatory pathways and postmarket surveillance of AI/ML safety events may address these challenges.
Authors
- Bhav Jain (ORCID: https://orcid.org/0000-0003-2648-4894)
- John C. H. Lin (ORCID: https://orcid.org/0000-0002-1976-0574)
- Chaerim Kang (ORCID: https://orcid.org/0000-0002-7507-0412)
- Jay M. Iyer
- Heta Patel (ORCID: https://orcid.org/0000-0001-8595-2323)
- Arjun Srinivasan (ORCID: https://orcid.org/0000-0002-9529-5344)
- Ravi B. Parikh
- Ishan Rola
Institutions
- Harvard University (US)
- Emory University (US)
- Brown University (US)
- The Ohio State University (US)
- University of Pennsylvania (US)
- Stanford University (US)
Publication Details
- Journal
- JAMA Health Forum
- Published
- 2025-09-26
- DOI
- https://doi.org/10.1001/jamahealthforum.2025.3351
- Citations
- 9
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 5.89
Funders
- U.S. Department of Defense
- Prostate Cancer Foundation
- Conquer Cancer Foundation
- National Comprehensive Cancer Network
- National Palliative Care Research Center
- Arnold Ventures
- Emerson Collective
- G1 Therapeutics
- Flatiron Health
- National Institutes of Health