Navigating Healthcare AI Governance: the Comprehensive Algorithmic Oversight and Stewardship Framework for Risk and Equity

Rahul Kumar^{1

2}, Kyle Sporn³, Ethan Waisberg⁴, Joshua Ong⁵, Phani Paladugu^{6

7}, Amar S Vadhera⁶, Dylan Amiri⁸, Alex Ngo⁹, Ram Jagadeesan^{10

11}, Alireza Tavakkoli¹², Timothy Loftus¹³, Andrew G Lee^{14

15}

Affiliations

¹ Department of Biochemistry and Molecular Biology, University of Miami Miller School of Medicine, Miami, USA. Rahul.Kumar5@umassmed.edu.
² University of Massachusetts Chan School of Medicine, Worcester, USA. Rahul.Kumar5@umassmed.edu.
³ SUNY Upstate Medical University, Syracuse, USA. spornk@upstate.edu.
⁴ University of Cambridge, Cambridge, UK. cambridgemlgroup@gmail.com.
⁵ Department of Ophthalmology and Visual Sciences, University of Michigan Kellogg Eye Center, Ann Arbor, USA.
⁶ Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, USA.
⁷ Brigham and Women's Hospital, Boston, USA.
⁸ University of Miami Miller School of Medicine, Miami, USA.
⁹ Department of Biochemistry and Molecular Biology, University of Miami Miller School of Medicine, Miami, USA.
¹⁰ Department of Computer Science, Johns Hopkins University Whiting School of Engineering, Baltimore, USA.
¹¹ Artificial Intelligence Systems, Cisco Inc., San Jose, USA.
¹² Department of Computer Science and Engineering, University of Nevada, Reno, USA.
¹³ TL Insight US, Miami, USA.
¹⁴ Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, Houston, USA.
¹⁵ The University of Texas MD Anderson Cancer Center, Houston, USA.

PMID: 40802160
DOI: 10.1007/s10728-025-00537-y

Navigating Healthcare AI Governance: the Comprehensive Algorithmic Oversight and Stewardship Framework for Risk and Equity

Rahul Kumar et al. Health Care Anal. 2025.

. 2025 Aug 13.

doi: 10.1007/s10728-025-00537-y. Online ahead of print.

Authors

Affiliations

¹ Department of Biochemistry and Molecular Biology, University of Miami Miller School of Medicine, Miami, USA. Rahul.Kumar5@umassmed.edu.
² University of Massachusetts Chan School of Medicine, Worcester, USA. Rahul.Kumar5@umassmed.edu.
³ SUNY Upstate Medical University, Syracuse, USA. spornk@upstate.edu.
⁴ University of Cambridge, Cambridge, UK. cambridgemlgroup@gmail.com.
⁵ Department of Ophthalmology and Visual Sciences, University of Michigan Kellogg Eye Center, Ann Arbor, USA.
⁶ Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, USA.
⁷ Brigham and Women's Hospital, Boston, USA.
⁸ University of Miami Miller School of Medicine, Miami, USA.
⁹ Department of Biochemistry and Molecular Biology, University of Miami Miller School of Medicine, Miami, USA.
¹⁰ Department of Computer Science, Johns Hopkins University Whiting School of Engineering, Baltimore, USA.
¹¹ Artificial Intelligence Systems, Cisco Inc., San Jose, USA.
¹² Department of Computer Science and Engineering, University of Nevada, Reno, USA.
¹³ TL Insight US, Miami, USA.
¹⁴ Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, Houston, USA.
¹⁵ The University of Texas MD Anderson Cancer Center, Houston, USA.

PMID: 40802160
DOI: 10.1007/s10728-025-00537-y

Abstract

Integrating artificial intelligence (AI) in healthcare has sparked innovation but exposed vulnerabilities in regulatory oversight. Unregulated "shadow" AI systems, operating outside formal frameworks, pose risks such as algorithmic drift, bias, and disparities. The Comprehensive Algorithmic Oversight and Stewardship (CAOS) Framework addresses these challenges, combining risk assessments, data protection, and equity-focused methodologies to ensure responsible AI implementation. This framework offers a solution to bridge oversight gaps while supporting responsible healthcare innovation. CAOS functions as both a normative governance model and a practical system design, offering a scalable framework for ethical oversight, policy development, and operational implementation of AI systems in healthcare.

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Conflict of interest statement

Declarations. Competing Interests: Dr. Andrew Lee: Amgen (speaker), Alexion (speaker); consultant Virdian, Ethyreal, Catalyst, AstraZeneca, Bristol Myers, Squibb, Stoke, US Department of Justice. Ram Jagadeesan: Cisco (Employee, Stock).

References

1. Krantz, T., Jonker, A., & McGrath, A. (2024). What is shadow AI? IBM think blog. October 25, https://www.ibm.com/think/topics/shadow-ai
1. El Chouffani, S., Abdullah, A., Fang, Y., et al. (2024). Not all AI health tools with regulatory authorization are clinically validated. Nature Medicine, 30, 2718–2720. https://doi.org/10.1038/s41591-024-03203-3 - DOI
1. Sokler, B. D., Hecht, A., & Fjeld, C. T. (2024). AI under a second Trump administration—AI: The Washington report. Mintz Insights November 15, https://www.natlawreview.com/article/ai-under-second-trump-administratio...
1. Armitage, H. (2024). Ambient artificial intelligence technology to assist Stanford medicine clinicians with taking notes. Stanford Medicine News Center Published March 11.
1. Food and Drug Administration (2018). Software as a medical device (SaMD). FDA Digital Health Center of Excellence Updated December 4.

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Navigating Healthcare AI Governance: the Comprehensive Algorithmic Oversight and Stewardship Framework for Risk and Equity

Affiliations

Navigating Healthcare AI Governance: the Comprehensive Algorithmic Oversight and Stewardship Framework for Risk and Equity

Authors

Affiliations

Abstract

Conflict of interest statement

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Abstract

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