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. 2025 Mar 18;8(1):165.
doi: 10.1038/s41746-025-01540-2.

Consternation as Congress proposal for autonomous prescribing AI coincides with the haphazard cuts at the FDA

Stephen Gilbert  1 , Tinglong Dai  2 , Rebecca Mathias  3
Affiliations

Consternation as Congress proposal for autonomous prescribing AI coincides with the haphazard cuts at the FDA

Stephen Gilbert et al. NPJ Digit Med. .

Abstract

We live in interesting regulatory times. In January, a bill was introduced to the US Congress proposing that AI “can qualify as a practitioner eligible to prescribe drugs” if overseen by the States and FDA. This a bold and contentious move. Even proponents of AI’s swift integration into medicine must recognize the deep paradox: this proposal emerges even as the FDA’s world-leading infrastructure for AI oversight faces dismantling.

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Conflict of interest statement

Competing interests: T.D. declares no competing financial interests and a nonfinancial interest as a member of multiple study teams using LumineticsCore from Digital Diagnostics and as co-lead of Johns Hopkins University’s Bloomberg Distinguished Professorship Cluster on Global Advances in Medical Artificial Intelligence. T.D. is an Editor for npj Digital Medicine. T.D. played no role in the internal review or decision to publish this News and Views article. R.M. declares no nonfinancial interests and no competing financial interests. S.G. declares a nonfinancial interest as an Advisory Group member of the EY-coordinated "Study on Regulatory Governance and Innovation in the field of Medical Devices" conducted on behalf of the DG SANTE of the European Commission. S.G. declares the following competing financial interests: he has or has had consulting relationships with Una Health GmbH, Lindus Health Ltd., Flo Ltd, ICURA ApS, Rock Health Inc., Thymia Ltd., FORUM Institut für Management GmbH, High-Tech Gründerfonds Management GmbH, DG SANTE, Prova Health Ltd, Haleon plc and Ada Health GmbH and holds share options in Ada Health GmbH. S.G. is a News and Views Editor for npj Digital Medicine. S.G. played no role in the internal review or decision to publish this News and Views article.

Figures

Fig. 1
Fig. 1. Autonomous AI with and without guardrails and effective regulatory oversight.
Autonomously prescribing AI could bring advantages for the public and for health systems, if appropriated developed and implemented under the 'green light' of suitable regulatory guardrails and oversight. However, it is critical that a 'red stop light' is shown to the introduction of speedily developed and inappropriately monitored autonomous prescribing systems, particularly if introduced alongside a disrupted and demotivated regulatory system.
See this image and copyright information in PMC

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