US Food and Drug Administration Shifts to AI-Enhanced Regulatory Review With Elsa 4.0 and HALO
Abstract
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.
Fields of Study & Subjects
Artificial Intelligence in Healthcare and Education
Law
AI
and Intellectual Property
COVID-19 Digital Contact Tracing
Publication details
- Journal / source
- Journal of Medical Internet Research
- Publisher
- JMIR Publications Inc.
- Volume
- 28
- Pages
- e101884–e101884
- Publication date
- 29 May 2026
- Language
- EN