US Food and Drug Administration Shifts to AI-Enhanced Regulatory Review With Elsa 4.0 and HALO

Unlabelled: The US Food and Drug Administration recently announced the launch of Elsa 4.0 and Harmonized AI and Lifecycle Operations for Data (HALO)-an upgrade to its artificial intelligence platform. In this News and Perspectives article, JMIR Correspondent Tejas S Athni reports on the evolution of the Elsa model and potential benefits and challenges.

Authors

Tejas S. Athni (ORCID: https://orcid.org/0000-0002-6336-0826)

Publication Details

Journal: Journal of Medical Internet Research
Published: 2026-05-29
DOI: https://doi.org/10.2196/101884
Primary Topic: Artificial Intelligence in Healthcare and Education
Type: article
Field-Weighted Citation Impact: 0.00

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article

US Food and Drug Administration Shifts to AI-Enhanced Regulatory Review With Elsa 4.0 and HALO

Tejas S. Athni

May 29, 2026

Journal of Medical Internet Research

Artificial Intelligence in Healthcare and Education

article

US Food and Drug Administration Shifts to AI-Enhanced Regulatory Review With Elsa 4.0 and HALO

Tejas S. Athni

May 29, 2026article en

Abstract

Journal of Medical Internet ResearchVol. 28

Openalex Percentile: Top 8%

Artificial Intelligence in Healthcare and Education

DOI Open Access PDF OpenAlex

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